FDA.reportPublic FDA data

Regard™

Primary DI
20194717105289
Brand
Regard™
Company
ROI CPS, LLC
Model
OB00988A
Published
2020-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20194717105289PackageGS14In Commercial Distribution
10194717105282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019471710528920194717105289
1019471710528210194717105282

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117174678
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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50198956402728CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-23
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50198956317527CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956376050CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956396317CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-19
50198956413212CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-16
50198956402506CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-10
50198956393279CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-09
50198956220384CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956327984CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956401622CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-06
50198956316612CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956320411CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956368826CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956394146CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956396980CARDINAL HEALTHCardinal Health 200, LLCOJF2026-03-02
50198956335934CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956357721CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956358278CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956376524CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956380576CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-23
50198956219371CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-13
50198956354256CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-13
50198956344684CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09
50198956346671CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09
50198956359398CARDINAL HEALTHCardinal Health 200, LLCOJF2026-02-09