What is FDA product code OGS?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Ear Nose & Throat › ProstheticMyringotomy Procedure Kit

BR Surgical, LLC

Name: BR Surgical, LLC
Brand: BR Surgical, LLC

Myringotomy Mini Set includes, Micro Ear Fcp, Hartmann Ear Specula 2mm-4mm, Buck Ear Curette blunt, Buck Ear Curette sharp, Barbara Needle curved, Day Ear Hook, Farrell Cotton Applicator,…

Registry build 21.09.26

Myringotomy Mini Set includes, Micro Ear Fcp, Hartmann Ear Specula 2mm-4mm, Buck Ear Curette blunt, Buck Ear Curette sharp, Barbara Needle curved, Day Ear Hook, Farrell Cotton Applicator, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12″x5 1/2″x3″

1manufacturer

2catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OGS
Manufacturer	City	Province	Registered as	Device types
GRI Medical & Electronic Technology Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	71

Record

Regulatory record for BR Surgical, LLC
Listed by	BR Surgical LLC, United States
FDA product code	OGS
Device type	Myringotomy Procedure Kit
Device class	Class 2
Regulation	21 CFR 874.3880
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2024-07-23

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Ethylene Oxide, Moist Heat or Steam Sterilization
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for BR Surgical, LLC
Catalogue number	Size	Status
BR980-9105		In distribution
BR46-90001		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	112
ACS	American Contract Systems, Inc.	4
Adept Medical	Jedmed Instrument Company	4
invenio	GRI Medical & Electronic Technology Co., Ltd.	2
Halyard	Avid Medical, Inc.	1
DeRoyal	Deroyal Industries, Inc.	1
Medical Action Industries	Medical Action Industries, Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.