VERASENSE SNN-JRNYBCS78-R
GUDID 00816818021126
ORTHOSENSOR INC
Arthroplasty force sensor| Primary Device ID | 00816818021126 |
| NIH Device Record Key | 4a4af358-83b2-4afe-b24a-eee471a8bd74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERASENSE |
| Version Model Number | VERASENSE for Smith & Nephew Journey II BCS 7-8 Ri |
| Catalog Number | SNN-JRNYBCS78-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
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 47 KiloPascal and 106 KiloPascal |
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816818021126 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150372
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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-02 |
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 |
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