AccessGUDID - DEVICE: Rim-Fix (05051693308046)

GUDID

Device Identifier (DI) Information

Brand Name: Rim-Fix
Version or Model: Poly Liner Neutral 62 x 32mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL3765
Company Name: IMPLANTS INTERNATIONAL LTD

Primary DI Number: 05051693308046
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346627222 *Terms of Use

Device Description: Poly Liner Neutral 62 x 32mm (UHMWPE) Uncemented

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?
44362	Constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.	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: 407398f6-e193-420c-9782-cdac0a4175b3
Public Version Date: April 08, 2024
Public Version Number: 3
DI Record Publish Date: July 31, 2016