FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956538481
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PB33RGM12
Catalog number
PB33RGM12
Device description
KIT, MAG ROBOTIC GYN
Published
2026-07-31
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
50198956538489PackageGS11In Commercial Distribution
10198956538481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653848950198956538489
1019895653848110198956538481

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
10885380152412CARDINAL HEALTHCAX2304BACAX2304BA2017-10-12
10885380152429CARDINAL HEALTHCAX2304BDCAX2304BD2017-10-12
10885380152559CARDINAL HEALTHCAX2330LACAX2330LA2021-10-27
10885380152566CARDINAL HEALTHCAX2330LDCAX2330LD2021-10-27
10885380171109CARDINAL HEALTHCAX1230LACAX1230LA2020-06-21
10885380171116CARDINAL HEALTHCAX1230LDCAX1230LD2020-06-21
10885380171147CARDINAL HEALTHCAX3030LACAX3030LA2020-06-21
10885380171154CARDINAL HEALTHCAX3030LDCAX3030LD2020-06-21
10885380164545CARDINAL HEALTHCAX5030LACAX5030LA2020-03-18
10885380164552CARDINAL HEALTHCAX5030LDCAX5030LD2020-03-18
10198956286306CARDINAL HEALTHSOPOCLRWSHSOPOCLRWSH2026-08-26
10198956330221CARDINAL HEALTHSBA5FLCABBSBA5FLCABB2026-08-26
10198956346246CARDINAL HEALTHSCVHDVPAGCSCVHDVPAGC2026-08-26
10198956373105CARDINAL HEALTHSNE43LMSUBSNE43LMSUB2026-08-26
10198956384330CARDINAL HEALTHSMA45DCWPBSMA45DCWPB2026-08-26
10198956409767CARDINAL HEALTHSEN18EAVBOSEN18EAVBO2026-08-26
10198956417533CARDINAL HEALTHSEY13EPLHMSEY13EPLHM2026-08-26
10198956423633CARDINAL HEALTHPOCGEXBLJPOCGEXBLJ2026-08-26
10198956437746CARDINAL HEALTH38-8433D38-8433D2026-08-26
10198956461048CARDINAL HEALTHSOP18FTSTMSOP18FTSTM2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956494053CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956546554CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956547599CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956550315CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956552579CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956561410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956563551CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956565289CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-26
10198956520851CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-18
10198956406964CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956427020CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956498419CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956505780CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956508828CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956520493CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10198956547841CARDINAL HEALTHCardinal Health 200, LLCOHD2026-08-17
10809160528334HALYARDAVID MEDICAL, INC.OHD2026-08-01
10198956368125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956393295CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956460669CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956475281CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956500174CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956503052CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956505322CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956513822CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956516823CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956523326CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956538580CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956543027CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956196261CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27