FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956341951
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANOCAPCUB
Catalog number
SANOCAPCUB
Device description
ARTERIOGRAM PACK
Published
2026-02-20
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
OERAngioscopic valvulotome kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OERAngioscopic Valvulotome KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956341959PackageGS12In Commercial Distribution
10198956341951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895634195950198956341959
1019895634195110198956341951

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. 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.

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956569744CARDINAL HEALTHCardinal Health 200, LLCOER2026-09-04
10198956539440CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-31
10198956494688CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-27
10198956534650CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-27
10198956527669CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-16
10198956492035CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-09
10198956494565CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-09
10198956398689CARDINAL HEALTHCardinal Health 200, LLCOER2026-07-06
10198956514102CARDINAL HEALTHCardinal Health 200, LLCOER2026-06-23
10198956487345CARDINAL HEALTHCardinal Health 200, LLCOER2026-05-25
10198956454514CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-27
10198956454545CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-15
10198956448421CARDINAL HEALTHCardinal Health 200, LLCOER2026-04-14
10198956422339CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
50198956422337CARDINAL HEALTHCardinal Health 200, LLCOER2026-03-23
10198956387522CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-24
10198956385184CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
50198956385182CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-23
50198956341959CARDINAL HEALTHCardinal Health 200, LLCOER2026-02-20
10198956339583CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
50198956339581CARDINAL HEALTHCardinal Health 200, LLCOER2026-01-26
10198956268524CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
50198956268522CARDINAL HEALTHCardinal Health 200, LLCOER2025-12-11
10198956266599CARDINAL HEALTHCardinal Health 200, LLCOER2025-11-21
10198956248502CARDINAL HEALTHCardinal Health 200, LLCOER2025-10-27
10198956169111CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
50198956169119CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-18
10198956160194CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
50198956160192CARDINAL HEALTHCardinal Health 200, LLCOER2025-08-06
10198956144958CARDINAL HEALTHCardinal Health 200, LLCOER2025-07-16