| Primary Device ID | 00810040689239 |
| NIH Device Record Key | 80a0bc94-a15d-428b-828e-3c78211433be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FPS |
| Version Model Number | F25-000062 |
| Catalog Number | F25-000062 |
| Company DUNS | 010968002 |
| Company Name | Tyber Medical, LLC |
| 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 | true |
| 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 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com | |
| Phone | +1(866)761-0933 |
| mschenk@tybermed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810040689239 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-08-15 |
| Device Publish Date | 2022-12-15 |
| 00810040689246 | Instrument Tray Lid |
| 00810040689239 | Small Frag Instruments |
| 00810040689222 | Mini Frag Instruments |
| 00810040689215 | Outer Case Lid |
| 00810040689208 | Outer Case |
| 00810040689192 | Ø4.0 Small Frag Screw Rack |
| 00810040689185 | Ø3.5 Small Frag Screw Rack |
| 00810040689178 | Ø3.0 Small Frag Screw Rack |
| 00810040689161 | Ø3.0 Mini Frag Screw Rack |
| 00810040689154 | Ø2.5 Mini Frag Screw Rack |
| 00810040689147 | Lapidus Caddy |
| 00810040689130 | MTP Caddy |
| 00810040689123 | Small TMT Caddy |
| 00810040689116 | Small Midfoot Caddy |
| 00810040689109 | Mini Midfoot Caddy |
| 00810040689093 | 5th Metatarsal Caddy |
| 00810040689086 | Small Frag Caddy |
| 00810040689079 | Mini Frag Caddy |
| 00810040689062 | Micro Frag Caddy |