FDA.reportPublic FDA data

Regard™

Primary DI
10194717112822
Brand
Regard™
Company
ROI CPS, LLC
Model
UR00279K
Device description
CYSTOSCOPY PACK
Published
2021-07-28
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
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717112829PackageGS18Not in Commercial Distribution
10194717112822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711282920194717112829
1019471711282210194717112822

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
10809160528112HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528136HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528174HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528181HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528198HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528051HalyardAVID MEDICAL, INC.LRO2026-07-29
10809160528099HalyardAVID MEDICAL, INC.LRO2026-07-29
10653160393511CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-28
10809160527955HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527962HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527993HalyardAVID MEDICAL, INC.LRO2026-07-28
10809160528044HalyardAVID MEDICAL, INC.LRO2026-07-28
10197106838556CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956355385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956359512CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956371965CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956384927CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956390102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956392885CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956393196CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956394735CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956400900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956401129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956406544CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956410268CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956423817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956443136CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445932CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956457829CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27