FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106165652
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN43RSTS4
Catalog number
SAN43RSTS4
Device description
RADIAL STEMI PACK
Published
2023-03-01
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
OIPRadiology-diagnostic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIPRadiology-Diagnostic KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106165650PackageGS12In Commercial Distribution
10197106165652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710616565050197106165650
1019710616565210197106165652

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956458482CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-27
10198956507074CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-27
10198956421226CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-20
10198956494749CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-20
10198956491526CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-09
10198956527959CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-09
10198956525252CARDINAL HEALTHCardinal Health 200, LLCOIP2026-07-06
10198956498693CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-08
10198956479449CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-05
10198956436220CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10198956473911CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10198956484696CARDINAL HEALTHCardinal Health 200, LLCOIP2026-06-01
10197106094143CARDINAL HEALTHCardinal Health 200, LLCOIP2024-01-10
10197106207574CARDINAL HEALTHCardinal Health 200, LLCOIP2023-09-27
10195594704599CARDINAL HEALTHCardinal Health 200, LLCOIP2023-06-01
10197106227787CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-31
10195594763831CARDINAL HEALTHCardinal Health 200, LLCOIP2023-05-16
10197106226872CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-20
10197106211441CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-05
10197106213117CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-05
10197106207680CARDINAL HEALTHCardinal Health 200, LLCOIP2023-04-03
10197106184530CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-21
10197106102053CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-15
10197106107928CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-10
10197106050521CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-08
10197106148761CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-02
10197106098493CARDINAL HEALTHCardinal Health 200, LLCOIP2023-03-01
10197106145982CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-23
10197106061718CARDINAL HEALTHCardinal Health 200, LLCOIP2023-02-16
10197106089743CARDINAL HEALTHCardinal Health 200, LLCOIP2023-01-30