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BR Surgical, LLC

FDA UDI

Class II (US FDA UDI)

by Br Surgical Llc

Identity

Trade Name
BR Surgical, LLC FDA UDI
Generic Name
ENT surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Myringotomy Kit, (5) per box, consisting of Ear Tube (Pope), Ear Tube (T Tube), Myringotomy Blade, Plastic Ear Speculum 4mm and 6mm, Gauze 4x4 12 ply (2), Large Cotton Ball (2), 2-Compartment Tray, CSR 20x20 Wrap, 10x15 Peel Pouch FDA UDI
Model / Reference
BR980-9105 FDA UDI
Description
Myringotomy Kit, (5) per box, consisting of Ear Tube (Pope), Ear Tube (T Tube), Myringotomy Blade, Plastic Ear Speculum 4mm and 6mm, Gauze 4x4 12 ply (2), Large Cotton Ball (2), 2-Compartment Tray, CSR 20x20 Wrap, 10x15 Peel Pouch FDA UDI

Identifiers

Catalog Number
BR980-9105 FDA UDI
Primary DI / UDI-DI
00840183512941 FDA UDI
FDA Product Code
OGS FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: ENT surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as ENT surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Br Surgical Llc

Sources (1)

  • FDA UDI c84a1c22-5c84-440a-a8cd-c518992526db 35 fields · synced May 30, 2026