| Primary Device ID | 00842078102275 |
| NIH Device Record Key | 5818f62c-646c-4882-bd00-7150e3c00e8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omni Plating |
| Version Model Number | 113-00120 |
| Company DUNS | 832720358 |
| Company Name | EXTREMITY MEDICAL, LLC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00842078102275 [Primary] |
| GAC | Rasp, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
[00842078102275]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-29 |
| Device Publish Date | 2026-01-21 |
| 00842078134047 | Fenestrating Drill |
| 00842078116401 | Drill Bit for 2.8 Screw (2.0 mm) |
| 00842078116128 | Fenestrating Drill (sterile) |
| 00842078114674 | Drill Bit for 3.5 Screw |
| 00842078102329 | Cup Spherical Rasp - 20 mm |
| 00842078102275 | Cone Spherical Rasp - 20 mm |