FDA.reportPublic FDA data

Regard™

Primary DI
10194717116325
Brand
Regard™
Company
ROI CPS, LLC
Model
OB00103AB
Device description
LAVH
Published
2022-11-15
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
OJFHysterectomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJFHysterectomy KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20194717116322PackageGS12Not in Commercial Distribution
10194717116325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471711632220194717116322
1019471711632510194717116325

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; 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
10193489412796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413113Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489414783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489424249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489427813Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428483Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489430677Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489431650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489432688Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489448498Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489450422Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428056Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-04-02
10194717116899Regard™ROI CPS, LLCOJF2023-02-10
10193489950052Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489984453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986228Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489986846Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-08-04
10193489432701Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-06-05
10194717115595Regard™ROI CPS, LLCOJF2022-04-14
10193489950298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27
10193489952810Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-03-27
10193489987096Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-02-20
10193489950489Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2022-02-13
10194717114321Regard™ROI CPS, LLCOJF2022-01-13
10193489950335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489950830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489952797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
10193489955224Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19