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.

Regard™ · Gynecological Laparoscopic Kit → Obstetrics & Gynecology

Name: Regard™
Brand: Regard™

1manufacturer

71catalogue numbers in this listing

1recall

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 Regard™
Listed by	ROi CPS LLC
FDA product code	OHD
Device type	Gynecological Laparoscopic Kit
Device class	Class 2
Regulation	21 CFR 884.1720
Premarket notification	Exempt
Record published	2021-07-07
Record revised	2025-04-11 (version 6)

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	Contains natural rubber latex
Label carries	lot or batch number, expiry date
Packaging	Pack of 2, pack of 3, pack of 4, pack of 6
Distribution end date	2025-06-05

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
GS01028D		Withdrawn
GY00437K		Withdrawn
GY00435T		Withdrawn
GS00366G		Withdrawn
OB00122W		Withdrawn
GY00435U		Withdrawn
OB00102R		Withdrawn
GY00964D		Withdrawn
GY00435R		Withdrawn
GY00939C		Withdrawn
GY00958E		Withdrawn
GS00403H		Withdrawn
GS00366I		Withdrawn
GY00437J		Withdrawn
GS00228K		Withdrawn
GY00436M		Withdrawn
GY01331		Withdrawn
GS00403L		Withdrawn
LD00186T		Withdrawn
GS01027D		Withdrawn
GS00403I		Withdrawn
GS00406N		Withdrawn
OB00548Q		Withdrawn
GY00436L		Withdrawn
GS00403K		Withdrawn
LD00186U		Withdrawn
GY00437L		Withdrawn
GS00228I		Withdrawn
GS01027C		Withdrawn
OB00548P		Withdrawn
GY01067C		Withdrawn
GS00366H		Withdrawn
GY00436P		Withdrawn
OB00102S		Withdrawn
GY00964B		Withdrawn
GY00436O		Withdrawn
GY00939D		Withdrawn
GS01028B		Withdrawn
GS01028C		Withdrawn
GY01330		Withdrawn
GY00435Q		Withdrawn
GY01067D		Withdrawn
GS00406O		Withdrawn
GY00436Q		Withdrawn
GY00435S		Withdrawn
OB00102T		Withdrawn
OB00122X		Withdrawn
GY01066C		Withdrawn
GY01066D		Withdrawn
GY00919B		Withdrawn
GY00437M		Withdrawn
GS01028F		Withdrawn
GY00958D		Withdrawn
GS00228J		Withdrawn
OB00548O		Withdrawn
GY01066B		Withdrawn
GY00919C		Withdrawn
GY00435P		Withdrawn
LD00186V		Withdrawn
GY00939E		Withdrawn
GY00939B		Withdrawn
GS00406Q		Withdrawn
GS00403J		Withdrawn
GY00383G		Withdrawn
GY00964C		Withdrawn
GS00406P		Withdrawn
OB00102Q		Withdrawn
GY00383F		Withdrawn
GY01066A		Withdrawn
GY01067A		Withdrawn
GS01028E		Withdrawn

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
DeRoyal	Deroyal Industries, Inc.	42
Regard™	Resource Optimization & Innovation, L.L.C.	26
Invenio	GRI Medical & Electronic Technology Co., Ltd.	15
BR Surgical, LLC	BR Surgical LLC	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

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Regard™
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
ROi CPS LLC	UDI-DI	2023-03-22	Class II	Nonconforming Material/Component	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.	386 kits

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.

Regard™