FDA.reportPublic FDA data

Regard™

Primary DI
10194717101994
Brand
Regard™
Company
ROI CPS, LLC
Model
GS00173D
Published
2019-11-19
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
20194717101991PackageGS110Not in Commercial Distribution
10194717101994PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710199120194717101991
1019471710199410194717101994

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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