FDA.reportPublic FDA data

Regard™

Primary DI
10194717102007
Brand
Regard™
Company
ROI CPS, LLC
Model
GS00174
Published
2020-01-09
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
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717102004PackageGS110Not in Commercial Distribution
10194717102007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710200420194717102004
1019471710200710194717102007

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
10198956310698CARDINAL HEALTHCardinal Health 200, LLCGCX2026-04-06
10198956435629CARDINAL HEALTHCardinal Health 200, LLCGCX2026-04-06
10198956355477CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
10198956417991CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
10198956375642CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
10198956277939CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
10198956289284CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-12
10198956261808CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10198956252127CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
10198956241909CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-04
10198956242098CARDINAL HEALTHCardinal Health 200, LLCGCX2025-10-22
10198956160859CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198956180383CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198459423567MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-21
10198459398063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-07
10198956073883CARDINAL HEALTHCardinal Health 200, LLCGCX2025-07-04
10198956033252CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-12
10198956087279CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-11
10198956097728CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-05
10198956083790CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
10198956013704CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-09
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08