VERASENSE ZBH-PSNCRGH712-R
GUDID 00816818021461
ORTHOSENSOR INC
Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor Arthroplasty force sensor| Primary Device ID | 00816818021461 |
| NIH Device Record Key | f603ef22-35df-49de-a5af-50ab9f26ef6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERASENSE |
| Version Model Number | VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Ri |
| Catalog Number | ZBH-PSNCRGH712-R |
| Company DUNS | 005788130 |
| Company Name | ORTHOSENSOR INC |
| 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 | true |
| Manufacturing Date | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 36 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816818021461 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180459
FDA Product Code
| ONN | Intraoperative Orthopedic Joint Assessment Aid |
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 | 2018-07-19 |
| Device Publish Date | 2018-06-18 |
On-Brand Devices [VERASENSE]
| 00816818021461 | VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Ri |
| 00816818021454 | VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Le |
| 00816818021447 | VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Ri |
| 00816818021430 | VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Le |
| 00816818021423 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Rig |
| 00816818021416 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Lef |
| 00816818021409 | VERASENSE for Zimmer NexGen PS E-F/5-6 |
| 00816818021393 | VERASENSE for Zimmer NexGen PS E-F/3-4 |
| 00816818021386 | VERASENSE for Zimmer NexGen PS C-D/3-4 |
| 00816818021379 | VERASENSE for Zimmer NexGen CR C-H/7-10 |
| 00816818021362 | VERASENSE for Zimmer NexGen CR C-H/5-6 |
| 00816818021355 | VERASENSE for Zimmer NexGen CR C-H/3-4 |
| 00816818021348 | VERASENSE for Stryker Triathlon size 7 |
| 00816818021331 | VERASENSE for Stryker Triathlon size 6 |
| 00816818021324 | VERASENSE for Stryker Triathlon size 5 |
| 00816818021317 | VERASENSE for Stryker Triathlon size 4 |
| 00816818021300 | VERASENSE for Stryker Triathlon size 3 |
| 00816818021294 | VERASENSE for Stryker Triathlon size 2 |
| 00816818021287 | VERASENSE for Smith & Nephew Legion CR size 7-8 |
| 00816818021270 | VERASENSE for Smith & Nephew Legion CR size 5-6 |
| 00816818021263 | VERASENSE for Smith & Nephew Legion CR size 3-4 |
| 00816818021256 | VERASENSE for Smith & Nephew Legion CR size 1-2 |
| 00816818021249 | VERASENSE for Smith & Nephew Legion PS size 7-8 |
| 00816818021232 | VERASENSE for Smith & Nephew Legion PS size 5-6 |
| 00816818021225 | VERASENSE for Smith & Nephew Legion PS size 3-4 |
| 00816818021218 | VERASENSE for Smith & Nephew Legion PS size 1-2 |
| 00816818021201 | VERASENSE for Smith & Nephew Journey II CR 7-8 Rig |
| 00816818021195 | VERASENSE for Smith & Nephew Journey II CR 7-8 Lef |
| 00816818021188 | VERASENSE for Smith & Nephew Journey II CR 5-6 Rig |
| 00816818021171 | VERASENSE for Smith & Nephew Journey II CR 5-6 Lef |
| 00816818021164 | VERASENSE for Smith & Nephew Journey II CR 3-4 Rig |
| 00816818021157 | VERASENSE for Smith & Nephew Journey II CR 3-4 Lef |
| 00816818021140 | VERASENSE for Smith & Nephew Journey II CR 1-2 Rig |
| 00816818021133 | VERASENSE for Smith & Nephew Journey II CR 1-2 Lef |
| 00816818021126 | VERASENSE for Smith & Nephew Journey II BCS 7-8 Ri |
| 00816818021119 | VERASENSE for Smith & Nephew Journey II BCS 7-8 Le |
| 00816818021102 | VERASENSE for Smith & Nephew Journey II BCS 5-6 Ri |
| 00816818021096 | VERASENSE for Smith & Nephew Journey II BCS 5-6 Le |
| 00816818021089 | VERASENSE for Smith & Nephew Journey II BCS 3-4 Ri |
| 00816818021072 | VERASENSE for Smith & Nephew Journey II BCS 3-4 Le |
| 00816818021065 | VERASENSE for Smith & Nephew Journey II BCS 1-2 Ri |
| 00816818021058 | VERASENSE for Smith & Nephew Journey II BCS 1-2 Le |
| 00816818021041 | VERASENSE for Biomet Vanguard PS size 79/83 |
| 00816818021034 | VERASENSE for Biomet Vanguard PS size 71/75 |
| 00816818021027 | VERASENSE for Biomet Vanguard PS size 63/67 |
| 00816818021010 | VERASENSE for Biomet Vanguard CR size 79/83 |
| 00816818021003 | VERASENSE for Biomet Vanguard CR size 71/75 |
| 00816818020990 | VERASENSE for Biomet Vanguard CR size 63/67 |
| 00816818020983 | VERASENSE for Zimmer NexGen PS E-F/5-6 |
| 00816818020976 | VERASENSE for Zimmer NexGen PS E-F/3-4 |
Trademark Results [VERASENSE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERASENSE 85882184 not registered Live/Pending |
Orthosensor, Inc. 2013-03-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.