Millennium

FDA UDI

Class I (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name: Millennium FDA UDI
Generic Name: Eye muscle hook, reusable FDA UDI
Device Name: Custom Duoble Ended Nucleus Chopper & Vertical Safety Chopper, titanium, left hand, FDA UDI
Model / Reference: 92-CUSTH002 FDA UDI
Description: Custom Duoble Ended Nucleus Chopper & Vertical Safety Chopper, titanium, left hand, FDA UDI

Identifiers

Primary DI / UDI-DI: 00190776379612 FDA UDI
FDA Product Code: HNQ FDA UDI
GMDN Term: Eye muscle hook, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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: Eye muscle hook, reusable

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

Similar devices

Also classified as Eye muscle hook, reusable.

Surgical Direct — SURGICAL DIRECT, INC. · Class I
Muscle Hook — SONTEC INSTRUMENTS, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Scobee Oblique Muscle Hook, 4.5mm — AURORA SURGICAL, LLC · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Surgical Direct — SURGICAL DIRECT, 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 c07d0f23-a296-4ee4-86f1-5d073ac693bf 34 fields · synced May 30, 2026