What is FDA product code OHD?

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.

Obstetrics & Gynecology › DiagnosticGynecological Laparoscopic Kit

BR Surgical, LLC

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

Hysteroscopy Sterile Procedure Kit, (5)/box: Hysteroscopy tubing, (2) Leggings, (Drapes: under buttock, video, drape sheet, back table), (2) Foam Prep Stick, (2) PVP 3/4 oz. pouch, (2) Blue…

Registry build 21.09.26

Hysteroscopy Sterile Procedure Kit, (5)/box: Hysteroscopy tubing, (2) Leggings, (Drapes: under buttock, video, drape sheet, back table), (2) Foam Prep Stick, (2) PVP 3/4 oz. pouch, (2) Blue OR Towels, Alcohol swabstick, Solution Prep Tray, Pouch

1manufacturer

15catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OHD
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	OHD
Device type	Gynecological Laparoscopic Kit
Device class	Class 2
Regulation	21 CFR 884.1720
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
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for BR Surgical, LLC
Catalogue number	Size	Status
BR980-9604-EACH		In distribution
BR980-9600		In distribution
BR980-9516		In distribution
BR980-9200-EACH		In distribution
BR980-9601-EACH		In distribution
BR980-9600-EACH		In distribution
BR980-9200		In distribution
BR980-9500		In distribution
BR980-9502		In distribution
BR980-9515		In distribution
BR980-9604		In distribution
BR980-9601		In distribution
BR980-9606		In distribution
BR980-9520		In distribution
BR980-9501		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	16,238
Medline Industries, Inc.	Medline Industries, Inc.	6,429
ACS	American Contract Systems, Inc.	739
Aligned Medical Solutions	Aligned Medical Solutions	112
Regard™	ROi CPS LLC	71
DeRoyal	Deroyal Industries, Inc.	42
Regard™	Resource Optimization & Innovation, L.L.C.	26
Invenio	GRI Medical & Electronic Technology Co., Ltd.	15
Medical Action Industries	Medical Action Industries, Inc.	13
Medline	Medline Industries, Inc.	11
Halyard	Avid Medical, Inc.	7
Centurion Medical Products Corp	Medline Industries, Inc.	4

Showing 12 of 14. All products under Gynecological Laparoscopic Kit

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.