Orthopedic Manual Surgical Instrument

FDA UDI

Class I (US FDA UDI)

by Fx Solutions

Identity

Trade Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: LONG STOP DRILL BIT Ø7.5mm FDA UDI
Model / Reference: 905-0045 FDA UDI
Description: LONG STOP DRILL BIT Ø7.5mm FDA UDI

Identifiers

Catalog Number: 905-0045 FDA UDI
Primary DI / UDI-DI: 03701037312346 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable Surgical drill guide, reusable

Orthopedic Manual Surgical Instrument by Fx Solutions — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

ORTHOFIX — Orthofix, Inc. · Class I
Titan™ — Ascension Orthopedics, Inc. · Class I
Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
Truliant — Exactech, Inc. · Class II
Vantage — Exactech, Inc. · Class II
Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · 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

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

Manufacturer

Manufacturer: Fx Solutions

Sources (1)

FDA UDI f80825f1-c742-4d96-8e84-7c9485275b48 35 fields · synced May 30, 2026