HawkOne H1-14550
GUDID 00821684057964
Cutter Driver
Covidien LP
Mechanical atherectomy system catheter, peripheral| Primary Device ID | 00821684057964 |
| NIH Device Record Key | 1512e11f-9dd8-4589-a8ec-fd3936899226 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HawkOne |
| Version Model Number | H1-14550 |
| Catalog Number | H1-14550 |
| Company DUNS | 968903703 |
| Company Name | Covidien LP |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 0.7 KiloPascal and 1.06 KiloPascal |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Handling Environment Temperature | Between 10 Degrees Celsius and 28 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821684057964 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141801
FDA Product Code
| MCW | Catheter, peripheral, atherectomy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-12 |
On-Brand Devices [HawkOne]
| 00821684057964 | Cutter Driver |
| 00821684057933 | Directional Atherectomy System, Large Vessel Extended Tip |
| 00821684057926 | Directional Atherectomy System, Large Vessel Standard Tip |
Trademark Results [HawkOne]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HAWKONE 86284715 4787076 Live/Registered |
Covidien LP 2014-05-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.