FDA UDI Not in Commercial Distribution 🇺🇸 United States

Arthrex®

DI: 00888867213524 · Model: RAR-9226ASI · ARTHREX, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Arthrex®
Primary DI
00888867213524
Version / Model
RAR-9226ASI
Catalog Number
RAR-9226ASI
Company Name
ARTHREX, INC.
Labeler DUNS
131747628
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-02-15
Public Version
7
Public Version Date
2021-07-28
Public Version Status
Update
Public Device Record Key
b78bcc2a-fda5-45f5-b2b2-6fff43a220c1
Distribution End Date
2021-07-27

Device Description

LOANER SET-UNIVERS APEX IMPLANT SET

Device Characteristics

Single Use
No
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KWS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

GMDN Terms

Code Name
34197 Uncoated shoulder humeral stem prosthesis

Identifiers

Type ID
Primary 00888867213524
Secondary M150RAR9226ASI0

Customer Contacts