Model: 02564066
DI: 04048844712815
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 insert 10° implacross® E
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
194937f6-3aa2-4269-bef8-1ee46e8542fb
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:
04048844712815
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43168
Name: Non-constrained polyethylene acetabular liner
Definition:
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 does not include a stabilizing component to limit the range of motion of the hip.
FDA Product Codes
OQI
Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented
Device Sizes
Device Size - Size Text:
Ø 40 mm / sz. G
Device Size - Size Type:
Device Size Text, specify