FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956519022
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA69CPWHF
Catalog number
SMA69CPWHF
Device description
C SECTION PACK
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
OHMCesarean section tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956519020PackageGS13In Commercial Distribution
10198956519022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895651902050198956519020
1019895651902210198956519022

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956450684CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956557574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956568136CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956572041CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956580848CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956586000CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956589186CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956271418CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956576902CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956580596CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584587CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584600CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956587090CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956450417CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-21
10809160538364HalyardMEDICAL ACTION INDUSTRIES INC.OHM2026-09-21
10198956514461CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956556676CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956562288CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570221CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570412CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956499720CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537279CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956563636CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956524262CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956556416CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956554627CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-17
10198956510944CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956516243CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956538726CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31