FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594623951
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA12GL383
Catalog number
SMA12GL383
Device description
GYN LAPAROSCOPIC PACK
Published
2022-04-06
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
50195594623959PackageGS13In Commercial Distribution
10195594623951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559462395950195594623959
1019559462395110195594623951

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS186920Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-26
10198956402522CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956485778CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956545953CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956547414CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956557109CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956567733CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956570764CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956587991CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956333758CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956346222CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956507807CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956539372CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956543423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567689CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567801CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956570115CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956577848CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956579613CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956580558CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581043CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581975CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956583436CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956589216CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956439610CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956521452CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956534278CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956571488CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956576360CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
B098AMS197460Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-18