What is FDA product code OJG?

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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™ · Neurological Tray → Neurology

Name: Regard™
Brand: Regard™

1manufacturer

208catalogue numbers in this listing

14recalls on this code

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJG
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	OJG
Device type	Neurological Tray
Device class	Class 1
Regulation	21 CFR 882.4525
Premarket notification	Exempt
Record published	2020-01-17
Record revised	2024-06-12 (version 4)

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 16, pack of 4
Distribution end date	2025-06-05

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
NU00840C		Withdrawn
NU00974F		Withdrawn
NU00921B		Withdrawn
NU01047A		Withdrawn
NU00937C		Withdrawn
NU00974H		Withdrawn
NU00259N		Withdrawn
NU01001J		Withdrawn
NU00698L		Withdrawn
NU00206M		Withdrawn
NU00974G		Withdrawn
NU00160W		Withdrawn
NU00140A		Withdrawn
NU00395L		Withdrawn
NU00962B		Withdrawn
NU00341I		Withdrawn
NU00168G		Withdrawn
NU01001I		Withdrawn
NU00698H		Withdrawn
NU00263O		Withdrawn
NU00206N		Withdrawn
NU00160V		Withdrawn
NU00748Q		Withdrawn
NU00921D		Withdrawn
NU00263T		Withdrawn
NU01018E		Withdrawn
NU00921E		Withdrawn
NU00974C		Withdrawn
NU00962F		Withdrawn
NU00160R		Withdrawn
NU00141AC		Withdrawn
NU01001G		Withdrawn
NU00010Y		Withdrawn
NU00140AC		Withdrawn
NU00263N		Withdrawn
NU00303K		Withdrawn
NU00168H		Withdrawn
NU00140AD		Withdrawn
NU01141A		Withdrawn
NU01001D		Withdrawn
NU00219P		Withdrawn
NU00041U		Withdrawn
NU00018Q		Withdrawn
NU00160T		Withdrawn
NU00140AB		Withdrawn
NU01049A		Withdrawn
NU01047B		Withdrawn
NU00096AG		Withdrawn
NU00141AA		Withdrawn
NU01086		Withdrawn
NU01141D		Withdrawn
NU00962D		Withdrawn
NU00259R		Withdrawn
NU00206O		Withdrawn
NU01018H		Withdrawn
NU00010Z		Withdrawn
NU00041V		Withdrawn
NU00010T		Withdrawn
NU00925D		Withdrawn
NU00040Q		Withdrawn
NU00160P		Withdrawn
NU00018T		Withdrawn
NU00840D		Withdrawn
NU00010X		Withdrawn
NU00962C		Withdrawn
NU01039E		Withdrawn
NU00991E		Withdrawn
NU00278L		Withdrawn
NU01140B		Withdrawn
NU01046A		Withdrawn
NU01001K		Withdrawn
NU00096AF		Withdrawn
NU00010AA		Withdrawn
NU00246K		Withdrawn
NU00395M		Withdrawn
NU01049B		Withdrawn
NU00010AD		Withdrawn
NU01018F		Withdrawn
NU00698K		Withdrawn
NU00303J		Withdrawn
NU00303I		Withdrawn
NU00921C		Withdrawn
NU00259O		Withdrawn
NU00748S		Withdrawn
NU00140AG		Withdrawn
NU00140AF		Withdrawn
NU00259Q		Withdrawn
NU00840E		Withdrawn
NU00041W		Withdrawn
NU00748R		Withdrawn
NU00141AD		Withdrawn
NU01001E		Withdrawn
NU00096AL		Withdrawn
NU00278M		Withdrawn
NU00748N		Withdrawn
NU00395I		Withdrawn
NU00974E		Withdrawn
NU00040S		Withdrawn
NU00961D		Withdrawn
NU00160U		Withdrawn
NU00141Z		Withdrawn
NU00010AB		Withdrawn
NU00141AF		Withdrawn
NU01046B		Withdrawn
NU00010W		Withdrawn
NU00925A		Withdrawn
NU00991F		Withdrawn
NU00018S		Withdrawn
NU00096AK		Withdrawn
NU00259P		Withdrawn
NU01018G		Withdrawn
NU00219O		Withdrawn
NU00141X		Withdrawn
NU00141V		Withdrawn
NU00246I		Withdrawn
NU00974D		Withdrawn
NU00096AH		Withdrawn
NU00980D		Withdrawn
NU00246J		Withdrawn
NU00981B		Withdrawn
NU00925B		Withdrawn
NU00263R		Withdrawn
NU00018R		Withdrawn
NU01140		Withdrawn
NU00018U		Withdrawn
NU00259U		Withdrawn
NU00698M		Withdrawn
NU00219S		Withdrawn
NU00909D		Withdrawn
NU00303L		Withdrawn
NU00991C		Withdrawn
NU00141Y		Withdrawn
NU00096AJ		Withdrawn
NU00961E		Withdrawn
NU00041T		Withdrawn
NU01039D		Withdrawn
NU01141C		Withdrawn
NU00748T		Withdrawn
NU00748P		Withdrawn
NU00140AH		Withdrawn
NU00246H		Withdrawn
NU00909B		Withdrawn
NU00206P		Withdrawn
NU01086A		Withdrawn
NU00168F		Withdrawn
NU01141		Withdrawn
NU00219R		Withdrawn
NU01048A		Withdrawn
NU00981C		Withdrawn
NU00278J		Withdrawn
NU00010V		Withdrawn
NU01141B		Withdrawn
NU00219T		Withdrawn
NU00141W		Withdrawn
NU00909C		Withdrawn
NU00395K		Withdrawn
NU00980C		Withdrawn
NU00981A		Withdrawn
NU00160Q		Withdrawn
NU00018O		Withdrawn
NU00980B		Withdrawn
NU00395H		Withdrawn
NU01086B		Withdrawn
NU00980A		Withdrawn
NU00962E		Withdrawn
NU00974B		Withdrawn
NU00937B		Withdrawn
NU00395J		Withdrawn
NU00363K		Withdrawn
NU00263P		Withdrawn
NU00160S		Withdrawn
NU00937D		Withdrawn
NU00141AB		Withdrawn
NU00278K		Withdrawn
NU00991D		Withdrawn
NU00698K		Withdrawn
NU01018I		Withdrawn
NU00010AC		Withdrawn
NU00961F		Withdrawn
NU01001F		Withdrawn
NU00018W		Withdrawn
NU00018P		Withdrawn
NU00974A		Withdrawn
NU00698I		Withdrawn
NU00193L		Withdrawn
NU00010U		Withdrawn
NU00096AI		Withdrawn
NU01048B		Withdrawn
NU00193N		Withdrawn
NU00303G		Withdrawn
NU00040R		Withdrawn
NU00018V		Withdrawn
NU00141AE		Withdrawn
NU00259T		Withdrawn
NU00303H		Withdrawn
NU00140AE		Withdrawn
NU01140A		Withdrawn
NU00974I		Withdrawn
NU00219Q		Withdrawn
NU00259S		Withdrawn
NU00160O		Withdrawn
NU00263Q		Withdrawn
NU00961C		Withdrawn
NU00925C		Withdrawn
NU00363J		Withdrawn
NU00748O		Withdrawn
NU01001H		Withdrawn
NU01018J		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	25,194
Medline Industries, Inc.	Medline Industries, Inc.	3,084
Avid TruCustom	Avid Medical, Inc.	969
ACS	American Contract Systems, Inc.	938
Halyard	Avid Medical, Inc.	718
Regard™	Resource Optimization & Innovation, L.L.C.	55
Aligned Medical Solutions	Aligned Medical Solutions	53
V. Mueller	Steris Corporation	27
Nico BrainPath Approach	Nico Corporation	25
V. Mueller	Carefusion 2200, Inc.	13
Invenio	GRI Medical & Electronic Technology Co., Ltd.	11
Phasor	Phasor Health, LLC	8

Showing 12 of 24. All products under Neurological Tray

Recalls Naming This Product

12 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Regard™
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
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.	456 kits
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	42 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	190 units	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	160 units	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	69 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	258 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	20 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	30 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	21 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	790 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	248 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	188 kits	2026-04-01

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	146 units	2026-04-01
2022-10-20	Class II	Component change control	Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.	38 kits	2026-04-01

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™