FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956529373
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA21GPP19
Catalog number
SMA21GPP19
Device description
GYN PACK
Published
2026-07-16
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
OHDGynecological laparoscopic kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956529371PackageGS13In Commercial Distribution
10198956529373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895652937150198956529371
1019895652937310198956529373

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.

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
10198956444768CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956453678CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956458055CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956518117CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956521759CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956526402CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956528420CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956528598CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956530119CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956530843CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956313576CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956333888CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956428003CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956467446CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956484467CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956485150CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956492349CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497634CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497672CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956504950CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956505773CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956509290CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956515543CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956525054CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956527423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956528079CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956477001CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956505612CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956509344CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956525184CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06