What is FDA product code OGR?

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 › SurgicalEar, Nose, And Throat Surgical Tray

BR Surgical, LLC

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

Minor FESS Set, includes: Weil Blakesley fcp 3.5mm str, Weil Blakesley fcp 3.5mm 45° up, Weil Blakesley Thru-Cut 3.5mm str, Weil Blakesley Thru-Cut 3.0mm 45° up, Turbinate Reduction fcp,…

Registry build 21.09.26

Minor FESS Set, includes: Weil Blakesley fcp 3.5mm str, Weil Blakesley fcp 3.5mm 45° up, Weil Blakesley Thru-Cut 3.5mm str, Weil Blakesley Thru-Cut 3.0mm 45° up, Turbinate Reduction fcp, Freer elevator s/b, Frontal Sinus Seeker, Maxillary Sinus Seeker, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12 1/4″ x 7 1/2″ x 2 1/2″

2manufacturers in China registered for this device type

3catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OGR
Manufacturer	City	Province	Registered as	Device types
Sino Protection (Hefei) Medical Products Co., Ltd.	Hefei	Anhui	Contract manufacturer	18
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	OGR
Device type	Ear, Nose, And Throat Surgical Tray
Device class	Class 1
Regulation	21 CFR 874.4420
Establishment	Specification developer, Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2024-10-30

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
BR980-9101		In distribution
BR46-90000		In distribution
BR46-90002		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	16,169
Medline Industries, Inc.	Medline Industries, Inc.	8,277
ACS	American Contract Systems, Inc.	472
Centurion	Centurion Medical Products Corporation	124
Regard™	ROi CPS LLC	76
Aligned Medical Solutions	Aligned Medical Solutions	75
Regard™	Resource Optimization & Innovation, L.L.C.	33
Centurion Medical Products Corp	Medline Industries, Inc.	22
Stradis Healthcare	Stradis Healthcare	15
Integra® MicroFrance®	Integra LifeSciences Production Corporation	14
Invenio	GRI Medical & Electronic Technology Co., Ltd.	14
DeRoyal	Deroyal Industries, Inc.	11

Showing 12 of 23. All products under Ear, Nose, And Throat Surgical Tray

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.