FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439301281
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA56SCMTT
Catalog number
SMA56SCMTT
Device description
C SECTION PACK
Published
2018-12-13
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
50888439301289PackageGS11In Commercial Distribution
10888439301281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843930128950888439301289
1088843930128110888439301281

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

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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10193489417081Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489418163Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489418989Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489419108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420524Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420739Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420876Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489423112Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489423181Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489424423Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489425598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489426267Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489426434Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489428711Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08