Primary Device ID | 03700879502922 |
NIH Device Record Key | c14ae067-a58f-454e-bd2c-d2d1c2431805 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | - |
Version Model Number | XFP01004 |
Catalog Number | XFP01004 |
Company DUNS | 264255288 |
Company Name | NOVASTEP |
Device Count | 1 |
DM Exempt | false |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
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 | 03700879502922 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
[03700879502922]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-28 |
Device Publish Date | 2023-12-20 |
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 |