| Primary Device ID | 00842078121023 |
| NIH Device Record Key | cfaf4889-16da-4312-a6e8-19604f4268aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omni ARCH |
| Version Model Number | 144-10004 |
| 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 | 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 | 00842078121023 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
[00842078121023]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-08 |
| Device Publish Date | 2024-03-29 |
| 00842078136553 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 12, Sterile |
| 00842078136560 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 14, Sterile |
| 00842078136577 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 16, Sterile |
| 00842078136584 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 18, Sterile |
| 00842078136591 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 20, Sterile |
| 00842078136607 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 22, Sterile |
| 00842078136614 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 24, Sterile |
| 00842078136621 - MetaFore | 2026-01-30 Partially Threaded Compression Screw Ø2.5 X 26, Sterile |