Avalign

FDA UDI

Class II (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name: Avalign FDA UDI
Generic Name: Endoscopic surgical probe FDA UDI
Device Name: Insulated Replaceable Shafts FDA UDI
Model / Reference: VM46-62211 FDA UDI
Description: Insulated Replaceable Shafts FDA UDI

Identifiers

Primary DI / UDI-DI: 00190776004187 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Endoscopic surgical probe 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

Dimensions & Sizes

Size: Width — 5 Millimeter FDA UDI
Length — 33 Centimeter FDA UDI

Category: Endoscopic surgical probe

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

Similar devices

Also classified as Endoscopic surgical probe.

Tecomet — Tecomet,Inc · Class I
ENDOTRAC — Stryker Corp. · Class II
MAGNETIC PROBE — SONTEC INSTRUMENTS, INC. · Class I
Tecomet — Tecomet,Inc · Class I
Novo Surgical — NOVO SURGICAL, INC. · Class I
MaxMoreSpine — Hoogland Spine Products, GmbH · Class I
Lightning — RESPONSIVE ORTHOPEDICS LLC · Class I
Rasp Probe — Biomet Orthopedics, 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 II	Pending data

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

Manufacturer

Manufacturer: AVALIGN TECHNOLOGIES, Inc.

Sources (1)

FDA UDI a84df59f-1f02-4b98-916a-b31a0e60269a 35 fields · synced May 30, 2026