FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106439577
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN23BTRW6
Catalog number
SAN23BTRW6
Device description
BIOPSY TRAY RMH
Published
2023-09-13
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
50197106439577PackageGS16In Commercial Distribution
10197106439579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710643957750197106439577
1019710643957910197106439579

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

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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956320718CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956364156CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-16
50198956401479CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-10
50198956323009CARDINAL HEALTHCardinal Health 200, LLCOFG2026-03-02
50198956336610CARDINAL HEALTHCardinal Health 200, LLCOFG2026-02-20
00191072241696ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-02-02
50198956337266CARDINAL HEALTHCardinal Health 200, LLCOFG2026-01-26
00191072241559ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2026-01-14
50198956203936CARDINAL HEALTHCardinal Health 200, LLCOFG2025-12-17
50198956267846CARDINAL HEALTHCardinal Health 200, LLCOFG2025-11-17
00191072239570ACSAMERICAN CONTRACT SYSTEMS, INC.OFG2025-09-29
50198956197440CARDINAL HEALTHCardinal Health 200, LLCOFG2025-09-22
50198956199987CARDINAL HEALTHCardinal Health 200, LLCOFG2025-09-19
50198956181364CARDINAL HEALTHCardinal Health 200, LLCOFG2025-08-27
40198459470760MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459474836MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459480233MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459481247MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459485092MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-18
40198459450489MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453695MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453701MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453725MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453770MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453787MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453794MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459453923MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459461690MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459462994MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11
40198459464738MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OFG2025-08-11