Foot Osteotomy Wedge System 60.844.100

GUDID 00819917028386

Wedge Instrument Graphic Case

Tyber Medical LLC

Instrument tray
Primary Device ID00819917028386
NIH Device Record Key9e507875-4dfd-422f-b294-b8f503b89264
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoot Osteotomy Wedge System
Version Model Number60.844.100
Catalog Number60.844.100
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
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com
Phone+1(866)761-0933
Emailjstigliano@tybermed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100819917028386 [Primary]

FDA Product Code

PXVGeneral purpose instrument tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

[00819917028386]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-03
Device Publish Date2020-01-24

On-Brand Devices [Foot Osteotomy Wedge System]

00819917028379Evans Osteotomy Trial, 22mm x 12mm
00819917028362Evans Osteotomy Trial, 20mm x 12mm
00819917028355Evans Osteotomy Trial, 20mm x 10mm
00819917028348Evans Osteotomy Trial, 20mm x 8mm
00819917028331Cotton Osteotomy Trial, 20mm x 6.5mm
00819917028324Cotton Osteotomy Trial, 20mm x 5.5mm
00819917028317Cotton Osteotomy Trial, 20mm x 4.5mm
00819917028300Ø2.4mm Pin (6")
00819917028294Straight Rod Inserter
00819917028249Evans Osteotomy Trial, 18mm x 8mm
00819917028232Evans Osteotomy Trial, 18mm x 10mm
00819917028225Cotton Osteotomy Trial, 16mm x 5.5mm
00819917028195Cotton Osteotomy Trial, 16mm x 4.5mm
00819917021875Evans Osteotomy Trial, 22mm x 10mm
00819917028270Hintermann Distractor
00819917028263“V” Tamp 6”
M695GTPC14955S0ACIF TyPEEK 14mm x 9mm x 5 deg Straight
M695GTPC14855S0ACIF TyPEEK 14mm x 8mm x 5 deg Straight
M695GTPC14755S0ACIF TyPEEK 14mm x 7mm x 5 deg Straight
M695GTPC14655S0ACIF TyPEEK 14mm x 6mm x 5 deg Straight
M695GTPC14555S0ACIF TyPEEK 14mm x 5mm x 5 deg Straight
M695GTPC141255S0ACIF TyPEEK 14mm x 12mm x 5 deg Straight
M695GTPC141155S0ACIF TyPEEK 14mm x 11mm x 5 deg Straight
M695GTPC141055S0ACIF TyPEEK 14mm x 10mm x 5 deg Straight
M6951407120CerviFuse Lordotic Spacer, 11 x 14 x 12mm
M6951407110CerviFuse Lordotic Spacer, 11 x 14 x 11mm
M6951407100CerviFuse Lordotic Spacer, 11 x 14 x 10mm
M6951407090CerviFuse Lordotic Spacer, 11 x 14 x 9mm
M6951407080CerviFuse Lordotic Spacer, 11 x 14 x 8mm
M6951407070CerviFuse Lordotic Spacer, 11 x 14 x 7mm
M6951407060CerviFuse Lordotic Spacer, 11 x 14 x 6mm
M6951407050CerviFuse Lordotic Spacer, 11 x 14 x 5mm
00819917028386Wedge Instrument Graphic Case
00819917028218Cotton Osteotomy Trial, 16mm x 6.5mm
00819917028201Cotton Osteotomy Trial, 16mm x 5.5mm
00819917028287Evans Osteotomy Trial, 18mm x 12mm
0081991702818808.844.312S
0081991702817108.844.310S
0081991702816408.844.308S
0081991702815708.844.212S
0081991702814008.844.210S
0081991702813308.844.208S
0081991702812608.844.206S
0081991702811908.844.205S
0081991702810208.844.204S
0081991702809608.844.112S
0081991702808908.844.110S
0081991702807208.844.108S
0081991702806508.844.106S
0081991702805808.844.105S
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