← Back to catalogue

Arthrex

FDA UDI

Class II (US FDA UDI)

by Provision

Identity

Trade Name
Arthrex FDA UDI
Generic Name
Arthroscopic shaver system blade, reprocessed FDA UDI
Model / Reference
AR-8350DS FDA UDI

Identifiers

Primary DI / UDI-DI
B504ASAR8350DS0 FDA UDI
510(k) Number
K172092 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Arthroscopic shaver system blade, reprocessed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Arthroscopic shaver system blade, reprocessed

Arthrex by Provision — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthroscopic shaver system blade, reprocessed.

Cleared under the same submission

K172092 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Provision

Sources (1)

  • FDA UDI da16f5d5-0364-47bb-92d0-88fd48f51103 35 fields · synced May 30, 2026