Millennium

FDA UDI

Class I (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name: Millennium FDA UDI
Generic Name: Orthopaedic cement extractor, manual FDA UDI
Device Name: Cement Removal T-Handle Conical Tap, medium, 14.5" shaft, 9mm wide, 17" OL FDA UDI
Model / Reference: 1-CR11 FDA UDI
Description: Cement Removal T-Handle Conical Tap, medium, 14.5" shaft, 9mm wide, 17" OL FDA UDI

Identifiers

Primary DI / UDI-DI: 00190776306175 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic cement extractor, manual 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 cement extractor, manual

Millennium by AVALIGN TECHNOLOGIES, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Viant Medical, LLC — Viant Medical, LLC · Class I
LINK Instruments - Chisel, bone curette, raspatory, rongeur — WALDEMAR LINK GmbH & Co. KG · Class I
LINK Instruments - Chisel, bone curette, raspatory, rongeur — WALDEMAR LINK GmbH & Co. KG · Class I
RENOVATION — Smith & Nephew, 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: AVALIGN TECHNOLOGIES, Inc.

Sources (1)

FDA UDI 63032e42-a970-403b-b135-76b266432f03 34 fields · synced May 30, 2026