FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956459946
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32A8642A
Catalog number
32A8642A
Device description
BIO TRAY 1
Published
2026-06-01
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
OFGCT biopsy tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFGCt Biopsy TrayCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956459944PackageGS126In Commercial Distribution
10198956459946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895645994450198956459944
1019895645994610198956459946

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 Temperature00

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956585874CARDINAL HEALTHCardinal Health 200, LLCOFG2026-09-22
10198956517097CARDINAL HEALTHCardinal Health 200, LLCOFG2026-09-21
10198956573079CARDINAL HEALTHCardinal Health 200, LLCOFG2026-09-04
10198956508293CARDINAL HEALTHCardinal Health 200, LLCOFG2026-07-27
10198956494589CARDINAL HEALTHCardinal Health 200, LLCOFG2026-07-06
10198956514713CARDINAL HEALTHCardinal Health 200, LLCOFG2026-06-23
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
10193489444995Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2023-04-30
10195327222550Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-08-14
10195327222987Medline 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
10195327197773Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-11
10195327199975Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFG2022-07-11