Model: 0220806800
DI: 04048844711771
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
cup cementless
Sterilization
Method Types - Sterilization Method:
Radiation Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3aa9baef-579b-454e-afa0-5b862ed3a068
Distribution Status:
In Commercial Distribution
DUNS Number:
324369826
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04048844711771
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43167
Name: Acetabular shell
Definition:
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.
FDA Product Codes
OQI
Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Device Sizes
Device Size - Size Text:
Ø 68 mm / sz. G
Device Size - Size Type:
Device Size Text, specify