AccessGUDID - DEVICE: Cermet Series III (05051693311091)

GUDID

Device Identifier (DI) Information

Brand Name: Cermet Series III
Version or Model: 10 Deg. Hood Acetabular Liner 58/60/62 x 48mm - 32mm Head
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AL3836
Company Name: IMPLANTS INTERNATIONAL LTD

Primary DI Number: 05051693311091
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 346627222 *Terms of Use

Device Description: Acetabular Liner for Acetabular Shell ( 32mm Head) (UHMWPE) 10 Deg. Hood 58/60/62 x 48mm

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
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071583	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: 07281459-f5f7-4613-9414-b8fa7a9a05da
Public Version Date: April 08, 2024
Public Version Number: 3
DI Record Publish Date: July 31, 2016