FDA.report

CARDINAL HEALTH

Primary DI
50197106941247
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAOCDCDCA
Catalog number
SMAOCDCDCA
Device description
D AND C PACK
Published
2025-02-21
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

Related Records

Product Codes

CodeName
PKFD and C tray

Product Code Classifications

CodeDeviceSpecialtyClass
PKFD And C TrayUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106941247PackageGS13In Commercial Distribution
10197106941249PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956385069CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-19
50198956407464CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-19
50198956412796CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-19
50198956313918CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-10
50198956333572CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-09
50198956407662CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-06
50198956332193CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956338652CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956389869CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956393880CARDINAL HEALTHCardinal Health 200, LLCPKF2026-03-02
50198956247152CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-23
50198956366136CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-20
50198956381313CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-20
50198956378184CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-17
50198956350159CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-13
50198956351651CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-13
50198956317947CARDINAL HEALTHCardinal Health 200, LLCPKF2026-02-09
50198956326932CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-30
50198956254037CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-22
50198956304053CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-13
50198956307092CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-13
50198956269932CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-05
50198956284232CARDINAL HEALTHCardinal Health 200, LLCPKF2026-01-05
50198956296327CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-31
50198956300550CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-22
50198956296020CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-17
50198956251227CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-11
50198956289176CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-11
50198956270655CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-10
50198956188561CARDINAL HEALTHCardinal Health 200, LLCPKF2025-12-09