FDA UDI Not in Commercial Distribution 🇺🇸 United States

Arthrex®

DI: 00888867213517 · Model: RAR-9200CAI · ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Arthrex®
Primary DI
00888867213517
Version / Model
RAR-9200CAI
Catalog Number
RAR-9200CAI
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
5
Public Version Date
2021-07-28
Public Version Status
Update
Public Device Record Key
91187b58-fcb7-4fa8-9c58-13159ea918a0
Distribution End Date
2021-07-27

Device Description

UNIVERS II HUMERAL CUFF TEAR ARTHROPATHY

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
HSD PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

GMDN Terms

Code Name
34197 Uncoated shoulder humeral stem prosthesis

Identifiers

Type ID
Primary 00888867213517
Secondary M150RAR9200CAI0

Customer Contacts