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: Hand-held surgical retractor, reusable FDA UDI
Device Name: TEBBETTS FIBEROPTIC RETRACTOR; 15CM X 20MM BLADE, WITHOUT TEETH, WITH ROUNDED EDGES FDA UDI
Model / Reference: B61185X FDA UDI
Description: TEBBETTS FIBEROPTIC RETRACTOR; 15CM X 20MM BLADE, WITHOUT TEETH, WITH ROUNDED EDGES FDA UDI

Identifiers

Catalog Number: B61185X FDA UDI
Primary DI / UDI-DI: 00840329831769 FDA UDI
FDA Product Code: FDG FDA UDI
GMDN Term: Hand-held surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.4530 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held surgical retractor, reusable

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

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Also classified as Hand-held surgical retractor, reusable.

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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 c766baaf-eb18-4559-aa87-045580aaf50a 35 fields · synced Jun 1, 2026