| Primary Device ID | 03700879517896 |
| NIH Device Record Key | ce74d90f-4c31-4078-9fbb-bd91a8c1166a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tarsoplasty® |
| Version Model Number | SKW05006 |
| Catalog Number | SKW05006 |
| Company DUNS | 264255288 |
| Company Name | NOVASTEP |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 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 |
| Phone | +33299338650 |
| contact@novastep-ortho.com | |
| Phone | +33299338650 |
| contact@novastep-ortho.com | |
| Phone | +33299338650 |
| contact@novastep-ortho.com | |
| Phone | +33299338650 |
| contact@novastep-ortho.com | |
| Phone | +33299338650 |
| contact@novastep-ortho.com | |
| Phone | +33299338650 |
| contact@novastep-ortho.com | |
| Phone | +33299338650 |
| contact@novastep-ortho.com | |
| Phone | +33299338650 |
| contact@novastep-ortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700879517896 [Primary] |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-07 |
| Device Publish Date | 2025-01-30 |
| 03700879517438 | Locking wheel |
| 03700879517452 | Threaded k-wire Ø1.8 Lg 70 TR/RD - sterile |
| 03700879517896 | Threaded k-wire Ø2.2 Lg 70 TR/RD - sterile |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TARSOPLASTY 97830636 not registered Live/Pending |
NOVASTEP 2023-03-09 |