FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956547841
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA29GNCCJ
Catalog number
SMA29GNCCJ
Device description
GYN BACK TABLE PACK
Published
2026-08-17
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
50198956547849PackageGS15In Commercial Distribution
10198956547841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895654784950198956547849
1019895654784110198956547841

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.

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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10198956538481CARDINAL 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
10198956385573CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956392410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956446632CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956448186CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956460676CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956469242CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956475182CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956485297CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27