| 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 |
| 03700879517445 - NA | 2024-09-20 K-wire Ø1.8 Lg 140 TR/RD - sterile |
| 03700879517452 - Tarsoplasty® | 2024-09-20 Threaded k-wire Ø1.8 Lg 70 TR/RD - sterile |
| 03700879516479 - arcad® 2.0 | 2024-08-16 Akin Compressive staple Duo 10x10x12 |
| 03700879517414 - NA | 2024-08-15 K-wire Ø1.8 Lg 140 TR/RD |
| 03700879517421 - NA | 2024-08-15 Threaded k-wire Ø1.8 Lg 70 TR/RD |
| 03700879517438 - Tarsoplasty® | 2024-08-15 Locking wheel |
| 03700879516486 - arcad® 2.0 | 2024-04-24 Compressive staple Duo 12x12 |
| 03700879516493 - arcad® 2.0 | 2024-04-24 Compressive staple Duo 15x15 |