Black & Black Surgical

FDA UDI

Class I (US FDA UDI)

by Black & Black Surgical, Inc.

Identity

Trade Name: Black & Black Surgical FDA UDI
Generic Name: Head-worn lamp FDA UDI
Device Name: VOROTEK "O SCOPE" - HEADBAND STNDRD KIT; 2 DIOPTER, 10HR BATT PK, CHARGER: RECOMM FOR MULTI USER NO BATTERY NO CHARGER FDA UDI
Model / Reference: B78481-NB FDA UDI
Description: VOROTEK "O SCOPE" - HEADBAND STNDRD KIT; 2 DIOPTER, 10HR BATT PK, CHARGER: RECOMM FOR MULTI USER NO BATTERY NO CHARGER FDA UDI

Identifiers

Catalog Number: B78481-NB FDA UDI
Primary DI / UDI-DI: 00840329833404 FDA UDI
FDA Product Code: EBA FDA UDI
GMDN Term: Head-worn lamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4630 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Head-worn lamp

Black & Black Surgical by Black & Black Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Black & Black Surgical, Inc.

Sources (1)

FDA UDI ee8a7c25-febc-4fef-bcc6-9a23f306a2f1 35 fields · synced May 30, 2026