FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425550494
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
13-4436D
Catalog number
13-4436D
Device description
STERILE RADIOLOGY BIOPSY KIT
Published
2016-07-05
Public version status
Update
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
OFGCt biopsy tray (kit)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425550492PackageGS120In Commercial Distribution
10885425550494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542555049250885425550492
1088542555049410885425550494

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials including a pharmaceutical component, intended to be used to assist a range of cardiothoracic surgical procedures. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device intended to be sterilized prior to use.

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
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
10198956494589CARDINAL HEALTHCardinal Health 200, LLCOFG2026-07-06
10198956514713CARDINAL HEALTHCardinal Health 200, LLCOFG2026-06-23
10198956459946CARDINAL HEALTHCardinal Health 200, LLCOFG2026-06-01
10195327227777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-13
10193489376449Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489417500Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489427080Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489427325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489429336Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489434958Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489442328Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489449211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10193489452143Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327028084Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327054588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
10195327092696Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-06-08
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10195327224783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-14
10195327214180Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-04
10195327208165Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327208554Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327213336Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-31
10195327195847Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327202934Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
10195327204921Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-17
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10195327199975Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-11