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Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Surgical staple loading unit, non-cutting FDA UDI
Device Name
STAPLE, SPIKED LIGAMENT, 8 X 20MM FDA UDI
Model / Reference
AR-1008NS FDA UDI
Description
STAPLE, SPIKED LIGAMENT, 8 X 20MM FDA UDI

Identifiers

Catalog Number
AR-1008NS FDA UDI
Primary DI / UDI-DI
00888867002500 FDA UDI
FDA Product Code
JDR FDA UDI
HXJ FDA UDI
GMDN Term
Surgical staple loading unit, non-cutting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Manufacturing Date

Yes

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

Category: Surgical staple loading unit, non-cutting

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

Similar devices

Also classified as Surgical staple loading unit, non-cutting.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrex, Inc.

Sources (1)

  • FDA UDI 662b34c8-92cf-4dfd-af56-86bd905646cb 35 fields · synced May 30, 2026