| Primary Device ID | 00840996169882 |
| NIH Device Record Key | bfedb8d4-8bb6-4435-872d-aeff574d1b1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gibralt Spine System |
| Version Model Number | 05-009-98-0045 |
| Company DUNS | 078293017 |
| Company Name | Choice Spine, LP |
| 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 |
| Phone | +1(865)246-3333 |
| info@choicespine.net |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840996169882 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840996169882]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-02-17 |
| 00840996169912 | GIBRALT,TAP,4.5 |
| 00840996169905 | GIBRALT,TAP,4.0 |
| 00840996169899 | GIBRALT,TAP,3.5 |
| 00840996169882 | GIBRALT,TAP,NO SLEEVE,4.5 |
| 00840996169875 | GIBRALT,TAP,NO SLEEVE,4.0 |
| 00840996169868 | GIBRALT,TAP,NO SLEEVE,3.5 |
| 00840996169851 | GIBRALT,TAP,NO SLEEVE,3.0 |
| 00840996169844 | GIBRALT,DRILL,ADUSTABLE,2.4 |
| 00840996166119 | GIBRALT,DRILL,ADUSTABLE,2.0 |
| 00840996160674 | GIBRALT, CONNECTOR, CAP |
| 00840996150323 | GIBRALT,SET SCREW,DRIVER,RETAINING SHAFT |