Offset Acetabular Reamer Driver Handle

FDA UDI

Class I (US FDA UDI)

by Incipio Devices

Identity

Trade Name: OFFSET ACETABULAR REAMER DRIVER HANDLE FDA UDI
Generic Name: Surgical power tool adaptor FDA UDI
Device Name: Offset Acetabular Reamer Driver - handle component accessory for use with Offset Reamer Handle assemblies FDA UDI
Model / Reference: 481100560 FDA UDI
Description: Offset Acetabular Reamer Driver - handle component accessory for use with Offset Reamer Handle assemblies FDA UDI

Identifiers

Catalog Number: 481100560 FDA UDI
Primary DI / UDI-DI: 07630055301819 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical power tool adaptor 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical power tool adaptor

Offset Acetabular Reamer Driver Handle by Incipio Devices — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Enztec ORD - Corin - Open - Zimmer — ENZTEC LIMITED · Class I
Enztec Straight Reamer Driver – Locking – Bridgeback – Large AO — ENZTEC LIMITED · Class I
HAMMR™ — Biomet Orthopedics, Inc. · 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: Incipio Devices

Sources (1)

FDA UDI fd72fb56-efac-400d-8db9-b75c4168488f 34 fields · synced Jun 8, 2026