| Primary Device ID | 00841506129990 |
| NIH Device Record Key | 21f289f4-002a-4f6f-a82a-60b7012ab623 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Proximal Ulna Plate |
| Version Model Number | Screw, FreeFix Locking, 3.5mm x 08mm, Ti |
| Catalog Number | FFL-35080-TS |
| Company DUNS | 869056148 |
| Company Name | SKELETAL DYNAMICS L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | 00841506129990 [Primary] |
| HWC | Screw, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
[00841506129990]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-29 |
| Device Publish Date | 2023-12-21 |
| 00841506134918 | PUP Extension, 2 Hole |
| 00841506134901 | PUP Extension, 1 Hole |
| 00841506134437 | FreeFix, Proximal Ulna Plate, 6 Slot, Left |
| 00841506134420 | FreeFix, Proximal Ulna Plate, 6 Slot, Right |
| 00841506134413 | FreeFix, Proximal Ulna Plate, 5 Slot Plus, Left |
| 00841506134406 | FreeFix, Proximal Ulna Plate, 5 Slot Plus, Right |
| 00841506134390 | FreeFix, Proximal Ulna Plate, 5 Slot, Left |
| 00841506134383 | FreeFix, Proximal Ulna Plate, 5 Slot, Right |
| 00841506134376 | FreeFix, Proximal Ulna Plate, 4 Slot, Left |
| 00841506134369 | FreeFix, Proximal Ulna Plate, 4 Slot, Right |
| 00841506134352 | FreeFix, Proximal Ulna Plate, 3 Slot, Left |
| 00841506134345 | FreeFix, Proximal Ulna Plate, 3 Slot, Right |
| 00841506134321 | FreeFix, Proximal Ulna Plate, 2 Slot, Right |
| 00841506134215 | Drill Guide, FreeFix™, PUP |
| 00841506131917 | Proximal Ulna Plating System, Sterilization Tray, |
| 00841506131900 | Proximal Ulna Plating System, Sterilization Tray, |
| 00841506131894 | Proximal Ulna Plating System, Sterilization Tray, |
| 00841506131887 | Proximal Ulna Plating System, Sterilization Tray, |
| 00841506131870 | Proximal Ulna Plating System, Sterilization Tray, |
| 00841506131689 | Proximal Ulna Plating System, Sterilization Tray ( |
| 00841506130224 | Screw, FreeFix™ Compression, 3.5mm x 08mm, Ti |
| 00841506129990 | Screw, FreeFix Locking, 3.5mm x 08mm, Ti |
| 00841506115719 | Drill, 3.5mm x 70mm, Reusable |
| 00841506134338 | FreeFix, Proximal Ulna Plate, 2 Slot, Left |
| 00841506131986 | Proximal Ulna Plating System |