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Avalign

FDA UDI

Class II (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name
Avalign FDA UDI
Generic Name
Neurosurgical rongeur FDA UDI
Device Name
Spurling Kerrison, Bayonet, Angled up 40°, TW 1 mm, WL 150 mm (6"), Black & Gold FDA UDI
Model / Reference
VM81-34318 FDA UDI
Description
Spurling Kerrison, Bayonet, Angled up 40°, TW 1 mm, WL 150 mm (6"), Black & Gold FDA UDI

Identifiers

Primary DI / UDI-DI
00190776130725 FDA UDI
FDA Product Code
HAE FDA UDI
GMDN Term
Neurosurgical rongeur FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4840 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Neurosurgical rongeur

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

Similar devices

Also classified as Neurosurgical rongeur.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AVALIGN TECHNOLOGIES, Inc.

Sources (1)

  • FDA UDI bf3bb893-926a-437a-9edc-ad61645e3a97 34 fields · synced May 31, 2026