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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
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
MAJOR Hysteroscopy Procedure Kit, (5) per box, consisting of hysteroscopy tubing, OB drape w/pouch, endoscopic cleaning brush and 2000cc fluid canister FDA UDI
Model / Reference
BR980-9516 FDA UDI
Description
MAJOR Hysteroscopy Procedure Kit, (5) per box, consisting of hysteroscopy tubing, OB drape w/pouch, endoscopic cleaning brush and 2000cc fluid canister FDA UDI

Identifiers

Catalog Number
BR980-9516 FDA UDI
Primary DI / UDI-DI
00840183513023 FDA UDI
FDA Product Code
OHD FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1720 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: General 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 General 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 495721c1-1462-463f-9d5e-360aff002014 35 fields · synced May 31, 2026