GRU Tibia GRU-1T-9.5-P-R

GUDID 09340499005263

GRU Tibia Size 1 9.5mm

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Uncoated unicondylar knee tibia prosthesis, polyethylene
Primary Device ID09340499005263
NIH Device Record Keyd4b03612-f968-4a10-9c64-4641178352f8
Commercial Distribution Discontinuation2021-07-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGRU Tibia
Version Model NumberGRU-1T-9.5-P-R
Catalog NumberGRU-1T-9.5-P-R
Company DUNS752039982
Company NameGLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au
Phone+6128870100
Emailinfo@globalortho.com.au

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS109340499005263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-07-14
Device Publish Date2016-03-23

On-Brand Devices [GRU Tibia]

09340499022697GRU Tibia Size -2 9.5mm
09340499022680GRU Tibia Size -2 8.5mm
09340499022673GRU Tibia Size -2 7.5mm
09340499022666GRU Tibia Size -2 6.5mm
09340499022659GRU Tibia Size -1 9.5mm
09340499022642GRU Tibia Size -1 8.5mm
09340499022635GRU Tibia Size -1 7.5mm
09340499022628GRU Tibia Size -1 6.5mm
09340499005423GRU Tibia Size 5 9.5mm
09340499005416GRU Tibia Size 5 8.5mm
09340499005409GRU Tibia Size 5 7.5mm
09340499005393GRU Tibia Size 5 6.5mm
09340499005386GRU Tibia Size 4 9.5mm
09340499005379GRU Tibia Size 4 8.5mm
09340499005362GRU Tibia Size 4 7.5mm
09340499005355GRU Tibia Size 4 6.5mm
09340499005348GRU Tibia Size 3 9.5mm
09340499005331GRU Tibia Size 3 8.5mm
09340499005324GRU Tibia Size 3 7.5mm
09340499005317GRU Tibia Size 3 6.5mm
09340499005300GRU Tibia Size 2 9.5mm
09340499005294GRU Tibia Size 2 8.5mm
09340499005287GRU Tibia Size 2 7.5mm
09340499005270GRU Tibia Size 2 6.5mm
09340499005263GRU Tibia Size 1 9.5mm
09340499005256GRU Tibia Size 1 8.5mm
09340499005249GRU Tibia Size 1 7.5mm
09340499005232GRU Tibia Size 1 6.5mm
09340499005225GRU Tibia Size 0 9.5mm
09340499005218GRU Tibia Size 0 8.5mm
09340499005201GRU Tibia Size 0 7.5mm
09340499005195GRU Tibia Size 0 6.5mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.