FDA.reportPublic FDA data

Regard™

Primary DI
10194717110460
Brand
Regard™
Company
ROI CPS, LLC
Model
ET01147
Device description
RESTORATIVE DENTISTRY
Published
2021-05-03
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
OFWRestorative Instrument And Component Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFWRestorative Instrument And Component TrayDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717110467PackageGS111Not in Commercial Distribution
10194717110460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711046720194717110467
1019471711046010194717110460

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any 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
10198956432109CARDINAL HEALTHCardinal Health 200, LLCOFW2026-05-08
10198956325388CARDINAL HEALTHCardinal Health 200, LLCOFW2026-03-16
50198956325386CARDINAL HEALTHCardinal Health 200, LLCOFW2026-03-16
10197106847596CARDINAL HEALTHCardinal Health 200, LLCOFW2024-12-20
10197106505762CARDINAL HEALTHCardinal Health 200, LLCOFW2024-02-02
50197106505760CARDINAL HEALTHCardinal Health 200, LLCOFW2024-02-02
10197106372876CARDINAL HEALTHCardinal Health 200, LLCOFW2023-07-19
50197106372874CARDINAL HEALTHCardinal Health 200, LLCOFW2023-07-19
10197106323892CARDINAL HEALTHCardinal Health 200, LLCOFW2023-06-15
50197106323890CARDINAL HEALTHCardinal Health 200, LLCOFW2023-06-15
10197106270974CARDINAL HEALTHCardinal Health 200, LLCOFW2023-05-11
50197106270972CARDINAL HEALTHCardinal Health 200, LLCOFW2023-05-11
10197106183878CARDINAL HEALTHCardinal Health 200, LLCOFW2023-03-10
50197106183876CARDINAL HEALTHCardinal Health 200, LLCOFW2023-03-10
10197106149409CARDINAL HEALTHCardinal Health 200, LLCOFW2023-02-17
50197106149407CARDINAL HEALTHCardinal Health 200, LLCOFW2023-02-17
10197106105719CARDINAL HEALTHCardinal Health 200, LLCOFW2023-01-19
10194717115083Regard™ROI CPS, LLCOFW2022-03-21
20194717115080Regard™ROI CPS, LLCOFW2022-03-21
20194717110467Regard™ROI CPS, LLCOFW2021-05-03
10888439973976CARDINAL HEALTHCardinal Health 200, LLCOFW2021-01-04
50888439973974CARDINAL HEALTHCardinal Health 200, LLCOFW2021-01-04
10887488722412CARDINAL HEALTHCardinal Health 200, LLCOFW2017-04-25
50887488722410CARDINAL HEALTHCardinal Health 200, LLCOFW2017-04-25