FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956595064
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PB13GYCFB
Catalog number
PB13GYCFB
Device description
KIT,GYN
Published
2026-10-19
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
50198956595062PackageGS11In Commercial Distribution
10198956595064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659506250198956595062
1019895659506410198956595064

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
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10198956602793CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-12
10809160540534HALYARDAVID MEDICAL, INC.OHD2026-10-12
10198956468733CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956514539CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956558786CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956567658CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956569911CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
10198956585034CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-06
B098AMS17355A0Aligned Medical SolutionsAligned Medical SolutionsOHD2026-10-05
10198956567832CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-30