Black & Black Surgical, Inc.

FDA UDI

Class I (US FDA UDI)

by Black & Black Surgical, Inc.

Identity

Trade Name: BLACK & BLACK SURGICAL, INC. FDA UDI
Generic Name: Liposuction system cannula, single-use FDA UDI
Device Name: SUTURE ROD 2MM X 29CM; 0.75MM PASS THROUGH HOLE 1CM FROM DISTAL END; ROUNDED BLUNT TIP ON PROXIMAL END FDA UDI
Model / Reference: B8XSR-229 FDA UDI
Description: SUTURE ROD 2MM X 29CM; 0.75MM PASS THROUGH HOLE 1CM FROM DISTAL END; ROUNDED BLUNT TIP ON PROXIMAL END FDA UDI

Identifiers

Catalog Number: B8XSR-229 FDA UDI
Primary DI / UDI-DI: 00840329834319 FDA UDI
FDA Product Code: GEA FDA UDI
GMDN Term: Liposuction system cannula, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

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: Liposuction system cannula, single-use

Black & Black Surgical, Inc. 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 ced04e40-a125-4e28-8e09-aaa9608392b6 35 fields · synced Jun 6, 2026