AccessGUDID - DEVICE: Rim-Fix (05051693309791)

GUDID

Device Identifier (DI) Information

Brand Name: Rim-Fix
Version or Model: DUAL COATED CUP - UNCEMENTED -62mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS4020
Company Name: IMPLANTS INTERNATIONAL LTD

Primary DI Number: 05051693309791
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346627222 *Terms of Use

Device Description: ACETABULAR DUAL COATED CUP UNCEMENTED -62mm (DUAL COATED) FOR UNCEMENTED APPLICATIONS

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
43167	Acetabular shell	An implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993713	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
Special Storage Condition, Specify: Room Temperature and Dry

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 62 Millimeter

Device Record Status

Public Device Record Key: 48a0ab80-9dc6-439f-a54f-643e5bcc3803
Public Version Date: April 08, 2024
Public Version Number: 4
DI Record Publish Date: July 31, 2016