RBK Patello Femoral GO-6000-2PFR-01

GUDID 09340499017785

RBK Patello Femoral Size 2 Right

GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Uncoated knee femur prosthesis, metallic
Primary Device ID09340499017785
NIH Device Record Key0d8c032a-9cc0-4d48-91d3-782527936eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameRBK Patello Femoral
Version Model NumberGO-6000-2PFR-01
Catalog NumberGO-6000-2PFR-01
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 Datetrue
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
Phone+6128870100
Emailinfo@globalortho.com.au

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS109340499017785 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRRProsthesis, Knee, Patello/Femoral, 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 Date2019-12-11
Device Publish Date2016-03-09

On-Brand Devices [RBK Patello Femoral]

09340499022710RBK Patello Femoral Size 4 Right
09340499022703RBK Patello Femoral Size 4 Left
09340499017808RBK Patello Femoral Size 3 Right
09340499017792RBK Patello Femoral Size 3 Left
09340499017785RBK Patello Femoral Size 2 Right
09340499017778RBK Patello Femoral Size 2 Left
09340499017761RBK Patello Femoral Size 1 Right
09340499017754RBK Patello Femoral Size 1 Left
09340499017747RBK Patello Femoral Size 0 Right
09340499017730RBK Patello Femoral Size 0 Left
09340499004662RBK Patella 40mm
09340499004655RBK Patella 36mm
09340499004648RBK Patella 32mm
09340499004631RBK Patella 28mm

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