FDA UDI Not in Commercial Distribution 🇺🇸 United States

Arthrex®

DI: 00888867228917 · Model: AR-8963RM-10 · ARTHREX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Arthrex®
Primary DI
00888867228917
Version / Model
AR-8963RM-10
Catalog Number
AR-8963RM-10
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
6
Public Version Date
2023-12-25
Public Version Status
Update
Public Device Record Key
54a384b1-0b7e-4130-8cf2-936678a2b1d6
Distribution End Date
2021-04-01

Device Description

2.7mm STRAIGHT PLATE, SS, 10H

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HRS Plate, fixation, bone

GMDN Terms

Code Name
46647 Orthopaedic fixation plate, non-bioabsorbable

Identifiers

Type ID
Primary 00888867228917
Secondary M150AR8963RM100

Customer Contacts