Arthrex®

FDA UDI

Class I (US FDA UDI)

by Arthrex, Inc.

Identity

Trade Name: Arthrex® FDA UDI
Generic Name: Orthopaedic trocar blade, reusable FDA UDI
Device Name: DILATOR, BIO-TRANSFIX FDA UDI
Model / Reference: AR-1373 FDA UDI
Description: DILATOR, BIO-TRANSFIX FDA UDI

Identifiers

Catalog Number: AR-1373 FDA UDI
Primary DI / UDI-DI: 00888867015135 FDA UDI
FDA Product Code: NBH FDA UDI
GMDN Term: Orthopaedic trocar blade, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.1100 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

Yes

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic trocar blade, reusable

Arthrex Orthopaedic Trocar Blade, a reusable and versatile surgical instrument designed for orthopedic surgeons to manually puncture soft tissue, assist in fracture location, and align surgical instruments/implants. This rigid hand-held device is made of high-grade stainless steel, titanium, or synthetic materials, making it an ideal solution for complex procedures.

Similar devices

Also classified as Orthopaedic trocar blade, reusable.

Trauma Fixation Systems — Biomet Orthopedics, Inc. · Class I
LEVEL ONE TRANSBUCCAL — KLS-Martin L.P. · Class I
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I
Adapterkabel Touchproof für ALM Tube — inomed Medizintechnik GmbH · Class I
EBA ONE — Citieffe · Class II
Tympanon-Elektrode mit 1, 5mm Sicherheitsstecker — inomed Medizintechnik GmbH · Class I
ARTHROLUTION — Richard Wolf GmbH · Class I
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Arthrex, Inc.

Sources (1)

FDA UDI 17e67103-7c60-4523-8eb3-5eba46a60d8a 35 fields · synced Jun 20, 2026