| Primary Device ID | 03700879517452 | 
| NIH Device Record Key | b07851e1-b4ae-44b3-afb1-c9a61e9900ec | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Tarsoplasty® | 
| Version Model Number | SKW05005 | 
| Catalog Number | SKW05005 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 03700879517452 [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 | 2024-09-20 | 
| Device Publish Date | 2024-09-12 | 
| 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  |