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Arthrex®

FDA UDI

Class II (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name
Arthrex® FDA UDI
Generic Name
Ligament reconstruction instrument set, reusable FDA UDI
Device Name
IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM FDA UDI
Model / Reference
AR-8914DS FDA UDI
Description
IMPLANT SYSTEM, MINI TIGHTROPE, 1.1 MM FDA UDI

Identifiers

Catalog Number
AR-8914DS FDA UDI
Primary DI / UDI-DI
00888867048881 FDA UDI
FDA Product Code
HTN FDA UDI
HWC FDA UDI
GMDN Term
Ligament reconstruction instrument set, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 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

Yes

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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Ligament reconstruction instrument set, reusable

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

Similar devices

Also classified as Ligament reconstruction instrument set, 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 a3a0d5a3-f00b-4af1-b4e7-96d936588473 35 fields · synced Jun 8, 2026