FDA.reportPublic FDA data

Regard™

Primary DI
10194717120841
Brand
Regard™
Company
ROI CPS, LLC
Model
OR00975I
Device description
TOTAL JOINT
Published
2024-12-26
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
20194717120848PackageGS11Not in Commercial Distribution
10194717120841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471712084820194717120848
1019471712084110194717120841

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
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10198956507678CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
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10198956509061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
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10198956514423CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
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10198956533783CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
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10198956538696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
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10198956552814CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
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10198956555259CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555471CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04
10198956555648CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-04