FDA UDI In Commercial Distribution 🇺🇸 United States

Arthrex®

DI: 00888867061071 · Model: AR-9501-12CPC · ARTHREX, INC.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Arthrex®
Primary DI
00888867061071
Version / Model
AR-9501-12CPC
Catalog Number
AR-9501-12CPC
Company Name
ARTHREX, INC.
Labeler DUNS
131747628
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-15
Public Version
17
Public Version Date
2024-01-03
Public Version Status
Update
Public Device Record Key
707e06a6-f779-4063-ad30-06b769c9bb1c

Device Description

UNIVERS REVERS STEM, SIZE 12, CAP COATED

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HRS PLATE, FIXATION, BONE
HWC Screw, fixation, bone
PHX Shoulder Prosthesis, Reverse Configuration

GMDN Terms

Code Name
33711 Total reverse shoulder prosthesis

Identifiers

Type ID
Primary 00888867061071
Secondary M150AR950112CPC2

Customer Contacts