Model: 103-61-07
Catalog: 103-61-07
DI: 10885862660541
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Trial Adaptor, Unipolar, O-Ring
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
91decdf7-61a2-44ae-a94c-13fb5db82fa6
Distribution Status:
In Commercial Distribution
DUNS Number:
157565946
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
10885862660541
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58479
Name: Femoral head prosthesis trial
Definition:
A copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
HWT
TEMPLATE
Device Sizes
Item #1 - Size Text:
12/14 Taper Angle
Item #1 - Size Type:
Device Size Text, specify
Item #2 - Size Text:
+7mm Offset
Item #2 - Size Type:
Device Size Text, specify