FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956326194
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA12GL38E
Catalog number
SMA12GL38E
Device description
GYN LAPAROSCOPIC PACK
Published
2026-02-09
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956326192PackageGS13In Commercial Distribution
10198956326194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895632619250198956326192
1019895632619410198956326194

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, medicated, single-useA 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, dressings, and pharmaceuticals. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29
10198956513310CARDINAL HEALTHSOP23SACACSOP23SACAC2026-10-29
10198956517240CARDINAL HEALTHSOP31KAOSXSOP31KAOSX2026-10-29
10198956521032CARDINAL HEALTHSENCGTACPCSENCGTACPC2026-10-29
10198956531932CARDINAL HEALTHSBA8CBPSPBSBA8CBPSPB2026-10-29
10198956533592CARDINAL HEALTHSAN42PMTMPSAN42PMTMP2026-10-29
10198956533653CARDINAL HEALTHSCV4AAAJHVSCV4AAAJHV2026-10-29
10198956534490CARDINAL HEALTHPU13CPAJEPU13CPAJE2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956485372CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956558045CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956571112CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956579071CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956594869CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956596825CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956605312CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956609969CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956610422CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956614727CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956619005CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-29
10198956516342CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956575028CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956603493CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956615564CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956616578CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956463417CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956584174CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956586437CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956586840CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956588653CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956589926CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956590878CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956595217CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956609754CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956612068CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956414815CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956552289CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956558601CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956564800CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19