Rocket R57525-00-T2
GUDID 05055270984296
Rocket DIsposable Needle Guide
ROCKET MEDICAL PLC
Needle guide, single-use| Primary Device ID | 05055270984296 |
| NIH Device Record Key | c5e7de41-7553-4828-ab39-20b00ebc207e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rocket |
| Version Model Number | R57525-00-T2 |
| Catalog Number | R57525-00-T2 |
| Company DUNS | 544313588 |
| Company Name | ROCKET MEDICAL PLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com | |
| Phone | +4401914196988 |
| gudid@rocketmedical.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 1.651 Millimeter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 101 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -5 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 1 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05055270984289 [Primary] |
| GS1 | 05055270984296 [Package] Contains: 05055270984289 Package: Inner [10 Units] In Commercial Distribution |
| GS1 | 05055270984302 [Package] Package: Outer [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032015
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-08 |
| Device Publish Date | 2023-10-31 |
On-Brand Devices [Rocket]
| 05055270942784 | Rocket LX 17G CVS Needle |
| 05055270973528 | Rocket 7Fg HSG Sonohystogram Catheter |
| 05055270973504 | Rocket 17G ZX Aspiration Needle |
| 05055270973474 | Rocket 24Fg Seldinger Chest Drainage Kit |
| 05055270973443 | Rocket IPC DRessing Pack & Bag |
| 05055270973412 | Rocket IPC Peritoneal Insertion Set |
| 05055270973382 | Rocket IPC Mini Dressing Pack & Bag |
| 05055270972552 | Rocket 17G ZX Aspiration Needle |
| 05055270972521 | Rocket IPC Peritoneal MINI Insertion Set |
| 05055270972491 | Rocket IPC Peritoneal Insertion Set |
| 05055270972460 | Rocket IPC DIscharge Pack |
| 05055270972316 | Rocket 6Fg Thoracentesis Drainage Kit |
| 05055270972286 | Rocket 8Fg Thoracentesis Drainage Kit |
| 05055270971654 | Rocket IPC Mini Dressing Pack & Bottle |
| 05055270971593 | Rocket DIsposable Needle Guide |
| 05055270971258 | Rocket DIsposable Needle Guide |
| 05055270971234 | Rocket IPC Dressing Pack |
| 05055270970411 | Rocket DIsposable Bellows Set |
| 05055270968050 | Rocket IPC Dressing Pack & Bag Set |
| 05055270967565 | Rocket Seldinger Wide Bore Connector |
| 05055270967473 | Rocket DIsposable Needle Guide |
| 05055270967411 | Rocket Dilator & Needle Set |
| 05055270967244 | Rocket Stylet 18cm ET Pro Handle |
| 05055270967213 | Rocket Stylet 23cm ET Pro Handle |
| 05055270966674 | Rocket Seldinger 0.35" Guide Wire |
| 05055270966490 | Rocket 26Fg Blunt DIssection Kit |
| 05055270966438 | Rocket 20Fg Seldinger Chest Drainage Kit |
| 05055270966407 | Rocket 28Fg Blunt DIssection Kit |
| 05055270966377 | Rocket 12Fg Seldinger Chest Drainage Kit |
| 05055270966346 | Rocket 12Fg Seldinger Chest Drainage Kit |
| 05055270966315 | Rocket 16Fg Seldinger Chest Drainage Kit |
| 05055270966285 | Rocket 18Fg Seldinger Chest Drainage Kit |
| 05055270966254 | Rocket 18Fg Seldinger Chest Drainage Kit |
| 05055270966131 | Rocket DIsposable Needle Guide |
| 05055270966094 | Rocket DIsposable Needle Guide |
| 05055270966063 | Rocket DIsposable Needle Guide |
| 05055270966032 | Rocket DIsposable Needle Guide |
| 05055270965929 | Rocket IPC DIscharge Pack |
| 05055270965899 | Rocket IPC Mini Dressing Pack & Bottle |
| 05055270965868 | Rocket IPC 600ml Drainage Bottle |
| 05055270965837 | Rocket IPC Dressing Pack & Bottle Set |
| 05055270965806 | Rocket IPC Insertion Set |
| 05055270965776 | Rocket IPC Pleural MINI Insert Set |
| 05055270965745 | Rocket IPC Pleural Insertion Set |
| 05055270965325 | Rocket ThoracentesIs Catheter 8Fg |
| 05055270964656 | Rocket Seldinger Catheter Fixation Set |
| 05055270965257 | Rocket BLUE Needle Drain Procedure Tray |
| 05055270965226 | Rocket 17G SX Aspiration Needle |
| 05055270964717 | Rocket Seldinger Fixation Set |
| 05055270964625 | Rocket DIsposable Needle Guide |
Trademark Results [Rocket]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROCKET 98744740 not registered Live/Pending |
True Temper Sports, Inc. 2024-09-11 |
 ROCKET 98360958 not registered Live/Pending |
Tzumi Electronics LLC 2024-01-17 |
 ROCKET 98157328 not registered Live/Pending |
Apro, LLC 2023-08-30 |
 ROCKET 98157322 not registered Live/Pending |
Apro, LLC 2023-08-30 |
 ROCKET 97765602 not registered Live/Pending |
Evonik Operations GmbH 2023-01-24 |
 ROCKET 97489984 not registered Live/Pending |
HART ENERGIA PROJETOS E ENGENHARIA EIRELI ME. 2022-07-06 |
 ROCKET 97430849 not registered Live/Pending |
Utility Associates, Inc. 2022-05-26 |
 ROCKET 97380103 not registered Live/Pending |
Be Accessible Inc 2022-04-25 |
 ROCKET 97350345 not registered Live/Pending |
Hohner Musikinstrumente GmbH 2022-04-06 |
 ROCKET 97263838 not registered Live/Pending |
Utility Associates, Inc. 2022-02-11 |
 ROCKET 97083523 not registered Live/Pending |
BeautyGarde, LLC 2021-10-20 |
 ROCKET 97047482 not registered Live/Pending |
ROCKET WORKS, LLC 2021-09-27 |
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