FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439705216
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA13DCMT2
Catalog number
SMA13DCMT2
Device description
D C
Published
2020-02-18
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
PKFD and C tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKFD And C TrayUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439705216PackageGS14In Commercial Distribution
10888439705218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843970521650888439705216
1088843970521810888439705218

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.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956527799CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-09
10198956423077CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956490949CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956491823CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956497658CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-08
10198956442467CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956482302CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956490536CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956487567CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10198956488502CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10195594785321CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-27
10195594804152CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-06
10195594808365CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-26
10195594830144CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-26
10195594837433CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-20
10195594827236CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-14
10195594714628CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-09
10195594813642CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594821906CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594825508CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594809140CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594814847CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594803599CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-02
10195594790059CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-29
10195594783594CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-26
10195594789336CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594790950CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594792329CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594781392CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-17
10195594729929CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-12