| Primary Device ID | 00819917026832 |
| NIH Device Record Key | ccb76fb0-53b4-4d60-a8b9-7d65642f3c27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cannulated Screw System + |
| Version Model Number | 03.333.213S |
| Catalog Number | 03.333.213S |
| Company DUNS | 010968002 |
| Company Name | Tyber 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 | true |
| 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(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com | |
| Phone | +1(866)761-0933 |
| jstigliano@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00819917026832 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-08-15 |
| Device Publish Date | 2020-05-21 |
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| 00196449024285 - Cannulated Headless Screw - Full Thread | 2025-09-29 1.4MM GUIDE WIRE/150MM LENGTH DOUBLE TROCAR TIP, 1PK, STER |
| 00196449024292 - Cannulated Headless Screw - Full Thread | 2025-09-29 1.6MM GUIDE WIRE/300MM LENGTH TROCAR TIP, 1PK |
| 00196449024308 - Cannulated Headless Screw - Full Thread | 2025-09-29 1.1MM GUIDE WIRE/150MM LENGTH DOUBLE TROCAR TIP, 1PK, STER |
| 00196449035557 - TOEGRIP® EVO | 2025-09-16 ToeGrip Evo Large 0° |
| 00196449035564 - TOEGRIP® EVO | 2025-09-16 ToeGrip Evo Large 10° |
| 00196449035571 - TOEGRIP® EVO | 2025-09-16 ToeGrip Evo Large 20° |
| 00196449035588 - TOEGRIP® EVO | 2025-09-16 ToeGrip Evo Medium 0° |