| 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 |
| 10811998039845 - OIC Variable Angle Small Fragment Locking Plate System | 2024-09-16 PROXIMAL HUMERUS PLATE 9 HOLE LEFT |
| 10811998039852 - OIC Variable Angle Small Fragment Locking Plate System | 2024-09-16 PROXIMAL HUMERUS PLATE 9 HOLE RIGHT |
| 10811998031924 - OIC Variable Angle Small Fragment Locking Plate System | 2024-06-28 STRAIGHT TIPPED REDUCTION CLAMP |
| 10811998030224 - OIC Cannulated Screw System | 2024-06-13 7 mm WASHER (SINGLE UNIT) |
| 10811998030248 - OIC Cannulated Screw System | 2024-06-13 13 mm WASHER (SINGLE UNIT) |
| 10811998030231 - OIC Cannulated Screw System | 2024-06-12 1.25 mm X 150 mm GUIDEPIN (SINGLE UNIT) |
| 10811998030255 - OIC Cannulated Screw System | 2024-06-12 2.8 mm X 300 mm GUIDEPIN (SINGLE UNIT) |
| 10811998030262 - OIC Cannulated Screw System | 2024-06-12 2.8 mm X 450 mm THREADED GUIDEPIN (SINGLE UNIT) |