Avalign

FDA UDI

Class II (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name: Avalign FDA UDI
Generic Name: Externally-anchored laparoscopic retractor FDA UDI
Device Name: Fan Retractor, straight,articulating shaft, shaft diameter 5mm, SL 335mm (13 1/8"), OL 475mm (18 3/4") FDA UDI
Model / Reference: VM46-82695X FDA UDI
Description: Fan Retractor, straight,articulating shaft, shaft diameter 5mm, SL 335mm (13 1/8"), OL 475mm (18 3/4") FDA UDI

Identifiers

Primary DI / UDI-DI: 00190776135867 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Externally-anchored laparoscopic retractor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 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

Category: Externally-anchored laparoscopic retractor

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

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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 cb6f2ae4-1ced-40eb-92b1-65f3971ee4e9 34 fields · synced Jun 8, 2026