| Primary Device ID | 00841506115887 |
| NIH Device Record Key | 01761198-0e0b-4d1c-96d6-460a5f6d50e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Forearm Plating System |
| Version Model Number | FreeFix Depth Gage |
| Catalog Number | DPGA-FF-050 |
| 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 | 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 | 00841506115887 [Primary] |
| HRS | Plate, fixation, bone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
[00841506115887]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-03 |
| Device Publish Date | 2020-11-25 |
| 00841506115887 | FreeFix Depth Gage |
| 00841506115740 | FreeFix Midshaft Radius Plate, 188mm |
| 00841506115399 | FreeFix Midshaft Ulna Plate, 157mm |
| 00841506115382 | FreeFix Midshaft Ulna Plate, 127mm |
| 00841506115375 | FreeFix Midshaft Ulna Plate, 112mm |
| 00841506114590 | FreeFix Midshaft Radius Plate, 142mm |
| 00841506114583 | FreeFix Midshaft Radius Plate, 112mm |
| 00841506114576 | FreeFix Midshaft Radius Plate, 81mm |
| 00841506113012 | FreeFix Midshaft Radius Plate, 157mm |
| 00841506112992 | FreeFix Midshaft Radius Plate, 97mm |
| 00841506112732 | Drill Guide, FreeFix™, 2.7mm |
| 00841506110011 | Universal Bending Irons, 3.5mm |
| 00841506109978 | Forceps, Bone Holding Medium, Long Ratcheting |
| 00841506108858 | Drill, Solid Side Cutting, 2.5mm x 40mm (OUS) |