Model: 1501-3202-N
DI: 00840097534299
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
Description
CoCr Glenosphere, Ø32 mm, +2 mm
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:
b10962b0-8dc5-483c-9763-ad3672debf5d
Distribution Status:
In Commercial Distribution
DUNS Number:
080819836
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:
00840097534299
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 48093
Name: Reverse shoulder prosthesis head
Definition:
A sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.
FDA Product Codes
PHX
Shoulder Prosthesis, Reverse Configuration
Premarket Submissions
Submission Number:
K243643
Supplement Number:
000