FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106288511
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA18CSGHK
Catalog number
SMA18CSGHK
Device description
C SECTION PACK
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106288519PackageGS15In Commercial Distribution
10197106288511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710628851950197106288519
1019710628851110197106288511

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 Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956510944CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956516243CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956538726CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956542303CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956360150CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956467965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956481602CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956490017CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956508750CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956510067CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956519916CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956529274CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531543CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531918CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956533936CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534179CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534957CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956535381CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956536005CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956536982CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956406162CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956454446CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956490994CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956491694CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956502086CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956505216CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956506510CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956512245CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956512986CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956532212CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20