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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 surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Minor Balloon Sinus Kit, (5) per box: 4-ply 17" x 19" Towel/Drape, 10cc Control Syringe, Neuro Sponges 1/2" x 3" (10 Patties/Card), 2oz Medicine Cups (3 per pack), 25ga x 3 1/2" Spinal Needle, Half Shallow Tray, 24" x 24" Wrap, Sterilization Pouch FDA UDI
Model / Reference
BR980-9101 FDA UDI
Description
Minor Balloon Sinus Kit, (5) per box: 4-ply 17" x 19" Towel/Drape, 10cc Control Syringe, Neuro Sponges 1/2" x 3" (10 Patties/Card), 2oz Medicine Cups (3 per pack), 25ga x 3 1/2" Spinal Needle, Half Shallow Tray, 24" x 24" Wrap, Sterilization Pouch FDA UDI

Identifiers

Catalog Number
BR980-9101 FDA UDI
Primary DI / UDI-DI
00840183528416 FDA UDI
FDA Product Code
OGR FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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 I — 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 8e5ba72c-0049-4dd5-9dc6-2183394cd1f7 35 fields · synced May 30, 2026