| Primary Device ID | 00841506109107 |
| NIH Device Record Key | d1ac257b-87d0-4392-9976-00a5bb76e80e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IJS-E |
| Version Model Number | IJS |
| Catalog Number | IJS-PUP-BPA |
| 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 | 00841506109107 [Primary] |
| OZI | Internal hinged elbow fixator |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
[00841506109107]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-28 |
| Device Publish Date | 2023-06-20 |
| 00841506109374 | IJS Sterilization Tray Implant & Screw Caddy |
| 00841506109305 | IJS Sterilization Tray |
| 00841506109138 | Twin IJS-E, Assembly |
| 00841506109107 | IJS-E Base Plate Assembly, Proximal Ulna Plate |
| 00841506107271 | Cutting Pliers |
| 00841506107226 | #4-40 Screws |
| 00841506105734 | Torque Limiting Handle, 20 in-lb |