| Primary Device ID | 00810030824565 |
| NIH Device Record Key | 7ab30314-f7d6-4f9c-baaf-3a34767470df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Headless Screw System Instruments |
| Version Model Number | T001000005 |
| Catalog Number | T001000005 |
| 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 | 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(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 | |
| 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 | |
| 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 | 00810030824565 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
[00810030824565]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-22 |
| Device Publish Date | 2020-01-14 |
| M6950011452090 | Ø4.5 (9") Drill |
| M6950010000090 | T4 (Solid) Torx |
| M6950010000040 | 1.6mm Guidewire (6") |
| 00810030825012 | Ø8.0 Screw Caddy |
| 00810030825005 | Ø6.5 Screw Caddy |
| 00810030824992 | Ø5.0 Screw Caddy |
| 00810030824985 | Ø4.0 Screw Caddy |
| 00810030824978 | Zimmer Biomet 8.0 Set |
| 00810030824961 | Zimmer Biomet 6.5 Set |
| 00810030824954 | Zimmer Biomet 5.0 Set |
| 00810030824947 | Zimmer Biomet 4.0 Set |
| 00810030824930 | Zimmer Biomet 1.5/2.0/2.5 Headed Set |
| 00810030824916 | 1.6mm Guidewire Dispenser (6”) |
| 00810030824909 | 1.1mm Guidewire Dispenser |
| 00810030824893 | 0.9mm Guidewire Dispenser |
| 00810030824886 | T30 (Ø2.8) Torx Driver (ZH) |
| 00810030824879 | T25 (Ø2.0) Torx Driver |
| 00810030824862 | T15 (Ø1.6) Torx Driver |
| 00810030824855 | T8 (Ø1.1) Torx Driver |
| 00810030824848 | T6 (Ø0.9) Torx Driver |
| 00810030824831 | T4 (Solid) Torx Driver |
| 00810030824824 | Ratcheting ZH Handle |
| 00810030824817 | Ratcheting AO Handle |
| 00810030824800 | Mini Fixed AO Handle |
| 00810030824794 | Tissue Protector 2.8mm x 5.5mm |
| 00810030824787 | Tissue Protector 2.0mm x 4.5mm |
| 00810030824770 | Tissue Protector 1.6mm x 3.5mm |
| 00810030824763 | Tissue Protector 1.6mm x 3.0mm |
| 00810030824756 | Tissue Protector 1.1mm x 2.0mm |
| 00810030824749 | Tissue Protector 0.9mm X 1.6mm |
| 00810030824732 | Ø5.5mm (9”) Drill |
| 00810030824725 | Ø4.5mm (9”) Drill |
| 00810030824718 | Ø3.5mm (9”) Drill |
| 00810030824701 | Ø3.0mm (6”) Drill |
| 00810030824695 | Ø2.0mm (6”) Drill |
| 00810030824688 | Ø1.6mm (6”) Drill |
| 00810030824671 | 9” Depth Gauge (Ø2.8) |
| 00810030824657 | 6" Depth Gauge |
| 00810030824640 | 8.0 Screw Countersink |
| 00810030824633 | 6.5 Screw Countersink |
| 00810030824626 | 5.0 Screw Countersink |
| 00810030824619 | 4.0 Screw Countersink |
| 00810030824589 | Ø2.8mm Guidewire (9”) |
| 00810030824572 | Ø2.0mm Guidewire (9") |
| 00810030824565 | Ø1.6mm Guidewire (9") |
| 00810030824558 | Ø1.6mm Guidewire (6") |
| 00810030824541 | Ø1.1mm Guidewire (6") |
| 00810030824534 | Ø0.9mm Guidewire (6") |
| M6950010000470 | 6.5 Screw Countersink |
| M6950010000430 | 4.5 Screw Countersink |