FDA.reportPublic FDA data

Regard™

Primary DI
10194717121114
Brand
Regard™
Company
ROI CPS, LLC
Model
OR01137B
Device description
EXTREMITY
Published
2024-12-30
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
20194717121111PackageGS12Not in Commercial Distribution
10194717121114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471712111120194717121111
1019471712111410194717121114

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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10198956384439CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
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10198956519541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
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10198956540958CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956544086CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956550063CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552104CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956552531CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556478CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956556591CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956557079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956564145CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567405CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956567931CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956569294CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570061CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956570078CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956573567CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956574571CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956575585CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956577275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956578197CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956580367CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956581142CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12