FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106671502
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA59CSKSO
Catalog number
SMA59CSKSO
Device description
C SECTION PACK
Published
2024-06-18
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
OHMCesarean section tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106671502PackageGS12In Commercial Distribution
10197106671504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710667150250197106671502
1019710667150410197106671504

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 Temperature15 Degrees Celsius30 Degrees Celsius

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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956312920CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956482203CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956495234CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956497832CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956498129CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956499249CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956231061CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956453227CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956466029CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956487239CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956489370CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956491984CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956493964CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956496323CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956467378CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956488120CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956489523CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956490444CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956490918CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956460614CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956462250CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956480056CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956487512CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956487574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956489431CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956493148CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10080196943470Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2025-02-16
10080196887545Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-07-29
10193489441772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-13
10193489212624Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08