AccessGUDID - DEVICE: GRU Femur (09340499005447)

GUDID

Device Identifier (DI) Information

Brand Name: GRU Femur
Version or Model: GRU-RL/LM-1F-C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GRU-RL/LM-1F-C
Company Name: GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Primary DI Number: 09340499005447
Issuing Agency: GS1
Commercial Distribution End Date: July 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 752039982 *Terms of Use

Device Description: GRU Femur RLLM Size 1

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33369	Uncoated unicondylar knee femur prosthesis	A sterile implantable device designed to replace the bearing surface of one femoral condyle (femoral component) during primary or revision unicompartmental replacement of the knee joint. It is made of metal [e.g., cobalt-chrome (Co-Cr)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device articulates with a tibial component and an insert, and its implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051721	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Size 0

Device Record Status

Public Device Record Key: 5140104d-ae67-43d8-bbfb-b0e5555f802e
Public Version Date: July 14, 2021
Public Version Number: 4
DI Record Publish Date: March 09, 2016