Millennium

FDA UDI

Class I (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name: Millennium FDA UDI
Generic Name: ENT elevator FDA UDI
Device Name: Goldman Displacer Septum Elevator, heavy blade, BW 6.4mm, OL 7 5/8" FDA UDI
Model / Reference: 1-400285 FDA UDI
Description: Goldman Displacer Septum Elevator, heavy blade, BW 6.4mm, OL 7 5/8" FDA UDI

Identifiers

Primary DI / UDI-DI: 00190776374112 FDA UDI
FDA Product Code: KAD FDA UDI
GMDN Term: ENT elevator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 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: ENT elevator

A comprehensive medical device directory entry for the Goldman Displacer Septum Elevator, a reliable and high-quality solution for ENT surgical procedures.

Similar devices

Also classified as ENT elevator.

BOSS Instruments — Boss Instruments, Ltd. · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
EVONOS — Gyrus Acmi, Inc. · Class I
Integra® — Integra LifeSciences Production Corporation · Class I
Ambler Value Line — Ambler Surgical, LLC · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Instrumentarium — Société Chirurgicale Instrumentarium Inc · Class I
ENDOSCOPIC FOREHEAD LIFTER — SONTEC INSTRUMENTS, 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

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

Manufacturer

Manufacturer: AVALIGN TECHNOLOGIES, Inc.

Sources (1)

FDA UDI 962a9e03-ef15-4a81-a785-e8751e4c5c17 34 fields · synced Jul 3, 2026