FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106184530
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN32RMI12
Catalog number
SAN32RMI12
Device description
RADIOLOGY MINOR PACK
Published
2023-03-21
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
50197106184538PackageGS12In Commercial Distribution
10197106184530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710618453850197106184538
1019710618453010197106184530

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.

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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956545496CARDINAL HEALTHCardinal Health 200, LLCOIP2026-08-17
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
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
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
10197106165652CARDINAL 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