What is FDA product code OJH?

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™ · Orthopedic Tray → General & Plastic Surgery

Name: Regard™
Brand: Regard™

1manufacturer

464catalogue numbers in this listing

18recalls on this code

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJH
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	OJH
Device type	Orthopedic Tray
Device class	Class 1
Regulation	21 CFR 878.4800
Premarket notification	Exempt
Record published	2021-01-26
Record revised	2021-01-26 (version 3)

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 12, pack of 6
Distribution end date	2025-06-05

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
OR01092B		Withdrawn
OR00058I		Withdrawn
OR00922D		Withdrawn
OR00031X		Withdrawn
OR01106A		Withdrawn
OR01111		Withdrawn
OR00452I		Withdrawn
OR01108A		Withdrawn
OR01029C		Withdrawn
OR01092		Withdrawn
NU00260H		Withdrawn
OR00011R		Withdrawn
OR00975D		Withdrawn
OR00123Y		Withdrawn
OR01105A		Withdrawn
OR01078B		Withdrawn
OR00233K		Withdrawn
OR00415I		Withdrawn
OR00107D		Withdrawn
OR01009D		Withdrawn
OR00734L		Withdrawn
OR00781I		Withdrawn
OR00970B		Withdrawn
OR00104AC		Withdrawn
OR00180U		Withdrawn
OR01152		Withdrawn
OR00093W		Withdrawn
OR00416K		Withdrawn
OR00836I		Withdrawn
OR00107AE		Withdrawn
OR00456J		Withdrawn
OR00451L		Withdrawn
OR01151A		Withdrawn
NU00260G		Withdrawn
OR00975I		Withdrawn
GS00828G		Withdrawn
OR00104A		Withdrawn
OR01151		Withdrawn
GS00125U		Withdrawn
NU00260J		Withdrawn
OR01055		Withdrawn
OR00150N		Withdrawn
OR00453F		Withdrawn
OR00749I		Withdrawn
OR00594I		Withdrawn
OR00094Y		Withdrawn
OR00124V		Withdrawn
OR00148N		Withdrawn
OR00798G		Withdrawn
OR01104D		Withdrawn
OR00048R		Withdrawn
OR01103C		Withdrawn
OR01254B		Withdrawn
OR01232A		Withdrawn
OR00296I		Withdrawn
OR00447F		Withdrawn
OR00355F		Withdrawn
OR00931C		Withdrawn
OR00697L		Withdrawn
OR01104A		Withdrawn
OR00208F		Withdrawn
OR00049P		Withdrawn
OR00124W		Withdrawn
OR00124Y		Withdrawn
OR00005AB		Withdrawn
OR01148A		Withdrawn
OR01056B		Withdrawn
OR00429L		Withdrawn
OR00429K		Withdrawn
OR01103B		Withdrawn
OR01100E		Withdrawn
OR00415H		Withdrawn
OR00993C		Withdrawn
OR01106B		Withdrawn
OR00123Z		Withdrawn
OR00351K		Withdrawn
OR00356E		Withdrawn
OR00159J		Withdrawn
OR00255I		Withdrawn
OR00384J		Withdrawn
OR00104AD		Withdrawn
OR00971C		Withdrawn
OR00045W		Withdrawn
GS01024C		Withdrawn
OR00255K		Withdrawn
OR00926B		Withdrawn
OR00134Q		Withdrawn
OR00148O		Withdrawn
OR01100B		Withdrawn
OR00280K		Withdrawn
OR00455J		Withdrawn
OR01077		Withdrawn
OR00347J		Withdrawn
OR00360J		Withdrawn
OR00960D		Withdrawn
OR00769L		Withdrawn
OR00798I		Withdrawn
OR00798H		Withdrawn
OR00344H		Withdrawn
OR01100F		Withdrawn
OR00107AH		Withdrawn
OR00949A		Withdrawn
OR00011T		Withdrawn
OR00697I		Withdrawn
GS00766E		Withdrawn
OR00005A		Withdrawn
OR00464H		Withdrawn
OR01108B		Withdrawn
OR00034P		Withdrawn
OR01103A		Withdrawn
OR00836P		Withdrawn
OR00022Q		Withdrawn
OR00045U		Withdrawn
OR00094W		Withdrawn
OR00969D		Withdrawn
OR00733E		Withdrawn
OR00209R		Withdrawn
OR00296J		Withdrawn
OR00824		Withdrawn
OR00452K		Withdrawn
OR01105C		Withdrawn
OR01100G		Withdrawn
OR00769M		Withdrawn
OR00106W		Withdrawn
OR00769J		Withdrawn
OR00734N		Withdrawn
OR01133A		Withdrawn
OR01055B		Withdrawn
OR00926C		Withdrawn
OR00765F		Withdrawn
OR00240N		Withdrawn
OR00799J		Withdrawn
OR01104		Withdrawn
NU00260L		Withdrawn
OR01103		Withdrawn
OR00922A		Withdrawn
OR00351L		Withdrawn
OR01056A		Withdrawn
OR00353L		Withdrawn
OR00841A		Withdrawn
OR01092A		Withdrawn
GS00950A		Withdrawn
OR00412K		Withdrawn
OR00360L		Withdrawn
OR00781K		Withdrawn
OR00350N		Withdrawn
OR00362K		Withdrawn
OR00159M		Withdrawn
OR00351M		Withdrawn
OR01112C		Withdrawn
OR01101A		Withdrawn
OR00106U		Withdrawn
OR00800L		Withdrawn
OR00360I		Withdrawn
OR00975F		Withdrawn
OR00993D		Withdrawn
OR01105		Withdrawn
OR00045X		Withdrawn
OR00989B		Withdrawn
OR01148B		Withdrawn
OR00977D		Withdrawn
OR00413F		Withdrawn
OR00209P		Withdrawn
OR01107A		Withdrawn
OR00733D		Withdrawn
OR00799H		Withdrawn
OR00697H		Withdrawn
OR00058H		Withdrawn
OR00424N		Withdrawn
OR00447F		Withdrawn
OR00442H		Withdrawn
OR00049O		Withdrawn
OR00255H		Withdrawn
OR00413E		Withdrawn
OR01014C		Withdrawn
OR00021S		Withdrawn
OR00970A		Withdrawn
OR00989C		Withdrawn
NU00260K		Withdrawn
OR01101		Withdrawn
OR00049Q		Withdrawn
OR00400O		Withdrawn
OR00800K		Withdrawn
OR01114A		Withdrawn
OR00949B		Withdrawn
OR00464I		Withdrawn
OR00429H		Withdrawn
OR00034Q		Withdrawn
OR01056		Withdrawn
OR00209O		Withdrawn
OR00400N		Withdrawn
OR00047O		Withdrawn
OR00094V		Withdrawn
OR00949C		Withdrawn
OR00960F		Withdrawn
OR01033D		Withdrawn
OR01112B		Withdrawn
OR01083B		Withdrawn
OR00094X		Withdrawn
OR00429I		Withdrawn
OR00362J		Withdrawn
OR00446F		Withdrawn
OR00903A		Withdrawn
OR01109B		Withdrawn
OR01112		Withdrawn
OR00960E		Withdrawn
OR00021Q		Withdrawn
OR00342K		Withdrawn
OB01037B		Withdrawn
OR00690O		Withdrawn
OR01061B		Withdrawn
OR00032V		Withdrawn
OR01137A		Withdrawn
OR01078		Withdrawn
GS00829G		Withdrawn
OR00836O		Withdrawn
OR00032U		Withdrawn
OR00903C		Withdrawn
OR00416J		Withdrawn
OR01113		Withdrawn
OR00031W		Withdrawn
OR00400P		Withdrawn
OR00106V		Withdrawn
OR00418M		Withdrawn
OR01108		Withdrawn
OR00124X		Withdrawn
OR00048O		Withdrawn
OR00821E		Withdrawn
OR01111A		Withdrawn
OR00362I		Withdrawn
OR00836N		Withdrawn
OR00972A		Withdrawn
OR01105B		Withdrawn
OB01037C		Withdrawn
OR01044C		Withdrawn
OR00124U		Withdrawn
OR00360K		Withdrawn
OR00353M		Withdrawn
OR01152A		Withdrawn
OR00031V		Withdrawn
OR00976A		Withdrawn
OR00265I		Withdrawn
OR00320M		Withdrawn
OR00354K		Withdrawn
GS00125V		Withdrawn
OR00449I		Withdrawn
OR00107AF		Withdrawn
OR01100D		Withdrawn
OR00769K		Withdrawn
OR01104B		Withdrawn

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cardinal Health	Cardinal Health 200, LLC	95,039
Medline Industries, Inc.	Medline Industries, Inc.	53,097
Avid TruCustom	Avid Medical, Inc.	3,990
ACS	American Contract Systems, Inc.	3,812
Halyard	Avid Medical, Inc.	1,313
Aligned Medical Solutions	Aligned Medical Solutions	1,272
Overwatch	Spinal Elements, Inc.	223
Regard™	Resource Optimization & Innovation, L.L.C.	191
Lucent L	Spinal Elements, Inc.	95
Invenio	GRI Medical & Electronic Technology Co., Ltd.	87
Integra®	Ascension Orthopedics, Inc.	81
Sapphire	Spinal Elements, Inc.	76

Showing 12 of 367. All products under Orthopedic Tray

Recalls Naming This Product

17 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.	1,369 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.	204 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.	326 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.	18 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.	164 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.	170 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.	38 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.	125 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.	456 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.	243 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.	213 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.	177 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.	28 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.	54 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.	24 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.	302 kits	2026-04-01
ROi CPS LLC	UDI-DI	2022-01-13	Class II	Under Investigation by firm	Products are mislabeled with the incorrect product identification on individual kit labeling.	50 kits	2022-09-28

Recalls

1 of these is 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.	90 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™