FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956587991
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PBOCLS942
Catalog number
PBOCLS942
Device description
KIT, GYN LAPAROSCOPY MAIMONIDE
Published
2026-09-25
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
50198956587999PackageGS11In Commercial Distribution
10198956587991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895658799950198956587999
1019895658799110198956587991

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical 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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956568334CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-30
10198956545335CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-29
10198956590120CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-29
10198956593978CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-29
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