GRU Femur GRU-RM/LL-0F-C

GUDID 09340499005492

GRU Femur RMLL Size 0

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Uncoated unicondylar knee femur prosthesis
Primary Device ID09340499005492
NIH Device Record Key11beaf99-63c3-42b1-b342-5309bbc9bc78
Commercial Distribution Discontinuation2021-07-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGRU Femur
Version Model NumberGRU-RM/LL-0F-C
Catalog NumberGRU-RM/LL-0F-C
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS109340499005492 [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 Date2016-03-09

On-Brand Devices [GRU Femur]

09340499005546GRU Femur RMLL Size 5
09340499005539GRU Femur RMLL Size 4
09340499005522GRU Femur RMLL Size 3
09340499005515GRU Femur RMLL Size 2
09340499005508GRU Femur RMLL Size 1
09340499005492GRU Femur RMLL Size 0
09340499005485GRU Femur RLLM Size 5
09340499005478GRU Femur RLLM Size 4
09340499005461GRU Femur RLLM Size 3
09340499005454GRU Femur RLLM Size 2
09340499005447GRU Femur RLLM Size 1
09340499005430GRU Femur RLLM Size 0

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