FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594246327
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA7CVHYN6
Catalog number
SMA7CVHYN6
Device description
ONCOLOGY ABD HYSTERECTOMY PK
Published
2021-08-13
Public version status
New
Distribution status
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
50195594246325PackageGS11In Commercial Distribution
10195594246327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559424632550195594246325
1019559424632710195594246327

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, non-medicatedA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, and dressings. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956451179CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-05
10198956487833CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10198956488069CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
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
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10193489950335Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19
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10193489955224Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2021-11-19