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Arthrex®

FDA UDI

Class I (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Device Name
HUDSON REAMER ATTACHMENT FDA UDI
Model / Reference
AR-01-02-012 FDA UDI
Description
HUDSON REAMER ATTACHMENT FDA UDI

Identifiers

Catalog Number
AR-01-02-012 FDA UDI
Primary DI / UDI-DI
00888867461635 FDA UDI
FDA Product Code
HWE FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Arthrex® by Arthrex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI b04c49e6-a9a2-4444-bab4-1adcd1563598 35 fields · synced Jun 8, 2026