BR Surgical, LLC

FDA UDI

Class I (US FDA UDI)

by Br Surgical Llc

Identity

Trade Name: BR Surgical, LLC FDA UDI
Generic Name: ENT speculum holder FDA UDI
Device Name: SHEA Speculum Holder, overall length 15 3/4" FDA UDI
Model / Reference: BR44-00000 FDA UDI
Description: SHEA Speculum Holder, overall length 15 3/4" FDA UDI

Identifiers

Catalog Number: BR44-00000 FDA UDI
Primary DI / UDI-DI: 00840183527402 FDA UDI
FDA Product Code: JYK FDA UDI
GMDN Term: ENT speculum holder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 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

Category: ENT speculum holder

BR Surgical, LLC by Br Surgical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as ENT speculum holder.

Integra® — Integra LifeSciences Production Corporation · Class I
Gyrus ACMI — Gyrus Acmi, Inc. · Class I
FENTEX — FENTEX medical GmbH · Class I
MicroFrance® — Integra Microfrance · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
FENTEX — FENTEX medical GmbH · Class I
Millennium — AVALIGN TECHNOLOGIES, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Br Surgical Llc

Sources (1)

FDA UDI d3ef35d2-1b97-41a0-ab77-6591ff7b3c28 35 fields · synced May 30, 2026