Headless Screw System Instruments TGC00008

GUDID 00810030824800

Mini Fixed AO Handle

Tyber Medical LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device ID00810030824800
NIH Device Record Key3582c3f6-7ad9-446c-b59f-580c93599679
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeadless Screw System Instruments
Version Model NumberTGC00008
Catalog NumberTGC00008
Company DUNS010968002
Company NameTyber Medical LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810030824800 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810030824800]

Moist Heat or Steam Sterilization

[00810030824800]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-22
Device Publish Date2020-01-14

On-Brand Devices [Headless Screw System Instruments]

M6950011452090Ø4.5 (9") Drill
M6950010000090T4 (Solid) Torx
M69500100000401.6mm Guidewire (6")
00810030825012Ø8.0 Screw Caddy
00810030825005Ø6.5 Screw Caddy
00810030824992Ø5.0 Screw Caddy
00810030824985Ø4.0 Screw Caddy
00810030824978Zimmer Biomet 8.0 Set
00810030824961Zimmer Biomet 6.5 Set
00810030824954Zimmer Biomet 5.0 Set
00810030824947Zimmer Biomet 4.0 Set
00810030824930Zimmer Biomet 1.5/2.0/2.5 Headed Set
008100308249161.6mm Guidewire Dispenser (6”)
008100308249091.1mm Guidewire Dispenser
008100308248930.9mm Guidewire Dispenser
00810030824886T30 (Ø2.8) Torx Driver (ZH)
00810030824879T25 (Ø2.0) Torx Driver
00810030824862T15 (Ø1.6) Torx Driver
00810030824855T8 (Ø1.1) Torx Driver
00810030824848T6 (Ø0.9) Torx Driver
00810030824831T4 (Solid) Torx Driver
00810030824824Ratcheting ZH Handle
00810030824817Ratcheting AO Handle
00810030824800Mini Fixed AO Handle
00810030824794Tissue Protector 2.8mm x 5.5mm
00810030824787Tissue Protector 2.0mm x 4.5mm
00810030824770Tissue Protector 1.6mm x 3.5mm
00810030824763Tissue Protector 1.6mm x 3.0mm
00810030824756Tissue Protector 1.1mm x 2.0mm
00810030824749Tissue Protector 0.9mm X 1.6mm
00810030824732Ø5.5mm (9”) Drill
00810030824725Ø4.5mm (9”) Drill
00810030824718Ø3.5mm (9”) Drill
00810030824701Ø3.0mm (6”) Drill
00810030824695Ø2.0mm (6”) Drill
00810030824688Ø1.6mm (6”) Drill
008100308246719” Depth Gauge (Ø2.8)
008100308246576" Depth Gauge
008100308246408.0 Screw Countersink
008100308246336.5 Screw Countersink
008100308246265.0 Screw Countersink
008100308246194.0 Screw Countersink
00810030824589Ø2.8mm Guidewire (9”)
00810030824572Ø2.0mm Guidewire (9")
00810030824565Ø1.6mm Guidewire (9")
00810030824558Ø1.6mm Guidewire (6")
00810030824541Ø1.1mm Guidewire (6")
00810030824534Ø0.9mm Guidewire (6")
M69500100004706.5 Screw Countersink
M69500100004304.5 Screw Countersink
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