Primary Device ID | 00810040689161 |
NIH Device Record Key | 3e7aa027-ac2a-4b7c-8a3f-fbc6ad0beadb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FPS |
Version Model Number | F25-000055 |
Catalog Number | F25-000055 |
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 | 00810040689161 [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 |