| Primary Device ID | 10811998039883 |
| NIH Device Record Key | 2cad464c-f64f-45b5-b2ef-9c869a3071c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OIC FLEX-FIX™ System |
| Version Model Number | FLEX-01-S |
| Company DUNS | 070061160 |
| Company Name | ORTHOPAEDIC IMPLANT COMPANY, THE |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Length | 6.35 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10811998039883 [Primary] |
| HTN | Washer, Bolt Nut |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-07 |
| Device Publish Date | 2024-05-30 |
| 10811998032150 - OIC Cannulated Screw System | 2026-02-09 IMPACTOR TIP |
| 10811998036301 - OIC Intramedullary Nail System | 2026-02-09 IMPACTOR IM NAIL |
| 10811998036325 - OIC Intramedullary Nail System | 2026-02-09 TISSUE PROTECTOR SLEEVE |
| 10811998036349 - OIC Intramedullary Nail System | 2026-02-09 4.2 MM DRILL SLEEVE |
| 10811998036387 - OIC Intramedullary Nail System | 2026-02-09 TISSUE PROTECTOR HIP NAIL LAG SCREW |
| 10811998036394 - OIC Intramedullary Nail System | 2026-02-09 GUIDE PIN SLEEVE |
| 10811998036561 - OIC Intramedullary Nail System | 2026-02-09 LONG IMPACTOR IM NAIL |
| 10811998038022 - OIC Intramedullary Nail System | 2026-02-09 TAPERED CANNULA |