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AVID TruCustom

FDA UDI

Class II (US FDA UDI)

by Avid Medical, Inc.

Identity

Trade Name
AVID TruCustom FDA UDI
Generic Name
Ophthalmic solid-state laser system, photodisruption FDA UDI
Model / Reference
GVVA004-05_0003 FDA UDI

Identifiers

Catalog Number
GVVA004-05 FDA UDI
Primary DI / UDI-DI
10809160209035 FDA UDI
FDA Product Code
OJK FDA UDI
GMDN Term
Ophthalmic solid-state laser system, photodisruption FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4790 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic solid-state laser system, photodisruption

AVID TruCustom by Avid Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic solid-state laser system, photodisruption.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avid Medical, Inc.

Sources (1)

  • FDA UDI 4e2280f0-8889-495b-85b3-c3c1af98c6f5 34 fields · synced May 29, 2026