FDA.reportPublic FDA data

Regard™

Primary DI
10194717120780
Brand
Regard™
Company
ROI CPS, LLC
Model
OR01100F
Device description
SPINE PACK
Published
2024-12-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJHOrthopedic Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717120787PackageGS11Not in Commercial Distribution
10194717120780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471712078720194717120787
1019471712078010194717120780

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
117174678
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10194717102298Regard™UR00857C2019-11-21
10194717102304Regard™UR00858B2019-10-28
10194717111733Regard™GS00372E2025-03-30
10194717112488Regard™GS00237H2021-07-19
10194717112990Regard™LD01002CD2021-08-24
10194717113959Regard™GS00310D2021-11-29
10194717113973Regard™GS00311C2021-11-29
10194717114741Regard™PL00126ST2022-02-17
10194717115144Regard™HT00253H2022-03-23
10194717115175Regard™CV00256LM2022-03-23
10194717115830Regard™PL00126T2022-04-28
10194717116028Regard™ET00701GH2022-06-28
10194717116066Regard™HT00253I2022-07-14
10194717121305Regard™GS01065D2025-01-21
20194717102295Regard™UR00857C2019-11-21
10194717100355Regard™UR00279I2019-10-28
10194717100812Regard™UR00847B2019-11-14
10194717104797Regard™UR00739I2019-11-07
10194717104834Regard™UR00746G2019-10-28
10194717106609Regard™UR00746H2019-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810135965088ToeJack Bunion Correction SystemNVision Biomedical Technologies, Inc.OJH2026-07-29
10809160527870HALYARDAVID MEDICAL, INC.OJH2026-07-28
10809160527979HALYARDAVID MEDICAL, INC.OJH2026-07-28
10198956301542CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956345898CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956354395CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956361652CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956362857CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956364431CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956365308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956369122CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956371910CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956372467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956377585CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956389564CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956390263CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956391192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956392182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956397323CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956406087CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956439405CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956446687CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956449541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956451261CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956452732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956453999CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956458369CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956461673CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956461833CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956463172CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27