FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956595217
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PB13DLCFB
Catalog number
PB13DLCFB
Device description
KIT,D AND C MINOR LITHOTOMY
Published
2026-10-23
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
50198956595215PackageGS11In Commercial Distribution
10198956595217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659521550198956595215
1019895659521710198956595217

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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10198956576766CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956586581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956586765CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956591103CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956594036CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956595064CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956607194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956608221CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956609440CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956577022CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-15
10198956573024CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-13
10198956568365CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956574199CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956583139CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956587885CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956588226CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10198956601970CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12