FDA UDI In Commercial Distribution 🇺🇸 United States

Arthrex®

DI: 00888867233089 · Model: AR-523-B1011 · ARTHREX, INC.
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Arthrex®
Primary DI
00888867233089
Version / Model
AR-523-B1011
Catalog Number
AR-523-B1011
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
5
Public Version Date
2024-01-04
Public Version Status
Update
Public Device Record Key
838e011a-9b85-4048-b84e-cd8865ae596f

Device Description

PS TIBIAL BEARING, SIZE 10, 11MM, VIT E

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
MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
KRR PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
HSX PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

GMDN Terms

Code Name
33666 Uncoated knee tibia/insert prosthesis

Identifiers

Type ID
Primary 00888867233089
Secondary M150AR523B10111

Customer Contacts