Bbig

FDA UDI

Class I (US FDA UDI)

by BBig B.V.

Identity

Trade Name: BBIG FDA UDI
Generic Name: Spectacle frame FDA UDI
Device Name: 20838180 FDA UDI
Model / Reference: 20838180 FDA UDI
Description: 20838180 FDA UDI

Identifiers

Primary DI / UDI-DI: 08719616005522 FDA UDI
FDA Product Code: HQZ FDA UDI
GMDN Term: Spectacle frame FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.5842 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Spectacle frame

The BBIG device is an ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user, typically consisting of a plastic or metallic frame supported by the nose and ears. It may have a protective function, such as side shields.

Similar devices

Also classified as Spectacle frame.

Fielmann — Fielmann Group AG · Class I
Fysh — WestGroupe Optical Inc · Class I
Kliik:denmark Eyewear — WestGroupe Optical Inc · Class I
Fielmann — Fielmann Group AG · Class I
EYEWEAR BY ROI WOODBURY BROWN — Eyewear By Roi, Limited · Class I
Daniel Hechter — MPG GmbH · Class I
Kazuo Kawasaki — MASUNAGA OPTICAL MFG.CO., LTD. · Class I
Superflex Kids Collection — WestGroupe Optical 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 I	Pending data

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Manufacturer

Manufacturer: BBig B.V.

Sources (1)

FDA UDI 9d52eb3b-20e7-4989-9a62-9e93e97f9349 33 fields · synced Jul 22, 2026