Primary Device ID | 03700879517445 |
NIH Device Record Key | ee9868d8-4abe-4de5-a014-733b3518552a |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | SKW01022 |
Catalog Number | SKW01022 |
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 | |
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 | 03700879517445 [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 |
03700879515342 - PECA® 2.0 | 2025-06-25 Bunion implant Ø3 lg16 |
03700879515359 - PECA® 2.0 | 2025-06-25 Bunion implant Ø3 lg18 |
03700879515366 - PECA® 2.0 | 2025-06-25 Bunion implant Ø3 lg20 |
03700879515373 - PECA® 2.0 | 2025-06-25 Bunion implant Ø3 lg22 |
03700879515380 - PECA® 2.0 | 2025-06-25 Bunion implant Ø3 lg24 |
03700879515397 - PECA® 2.0 | 2025-06-25 Bunion implant Ø3 lg26 |
03700879516196 - PECA® 2.0 | 2025-06-25 Removal AO T15 screwdriver tip |
03700879516202 - PECA® 2.0 | 2025-06-25 Exact2-T®15 AO screwdriver tip |