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Avalign

FDA UDI

Class II (US FDA UDI)

by AVALIGN TECHNOLOGIES, Inc.

Identity

Trade Name
Avalign FDA UDI
Generic Name
Laparoscope system, reusable FDA UDI
Device Name
Laparoscope, Autoclavable, Angled 30 Degrees,Diameter 5mm WL300mm(11 7/8"),OL359mm(14 1/8") FDA UDI
Model / Reference
VM46-0346 FDA UDI
Description
Laparoscope, Autoclavable, Angled 30 Degrees,Diameter 5mm WL300mm(11 7/8"),OL359mm(14 1/8") FDA UDI

Identifiers

Primary DI / UDI-DI
00190776147242 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Laparoscope system, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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: Laparoscope system, reusable

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

Similar devices

Also classified as Laparoscope system, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 0469ffbc-838a-41f4-b1ed-51e819118aa4 34 fields · synced May 30, 2026