Avalign

FDA UDI

Class II (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name: Avalign FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: Janetta Retractor Blade FDA UDI
Model / Reference: VM84-3625 FDA UDI
Description: Janetta Retractor Blade FDA UDI

Identifiers

Primary DI / UDI-DI: 00190776016722 FDA UDI
FDA Product Code: GZT FDA UDI
GMDN Term: Self-retaining surgical retractor, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4800 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

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

Dimensions & Sizes

Size: Length — 7.5 Inch FDA UDI
Width — 20 Millimeter FDA UDI
Length — 95 Millimeter FDA UDI

Category: Self-retaining surgical retractor, reusable

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

Similar devices

Also classified as Self-retaining surgical retractor, reusable.

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Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I
Power Dental USA — Power Dental USA, Inc. · Class I
BOSS Instruments — Boss Instruments, Ltd. · 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 II	Pending data

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Manufacturer

Manufacturer: AVALIGN TECHNOLOGIES, Inc.

Sources (1)

FDA UDI 054f5578-30d8-4283-9367-85d986b5b798 35 fields · synced Jun 8, 2026