FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956467378
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA21CSFCB
Catalog number
SMA21CSFCB
Device description
C SECTION PACK
Published
2026-06-03
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956467376PackageGS12In Commercial Distribution
10198956467378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646737650198956467376
1019895646737810198956467378

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956445048CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956496422CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956506442CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956529038CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956268272CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956460423CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956478985CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956485082CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956491243CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956497603CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956509870CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956519060CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956527508CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956528116CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956487079CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-06
10198956526044CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-06
10198956493780CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-23
10198956515154CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-23
10198956312920CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956482203CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956495234CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956497832CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956498129CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956499249CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956231061CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956453227CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956466029CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956487239CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956489370CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956491984CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05