FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594531393
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANCGIPIPB
Catalog number
SANCGIPIPB
Device description
IR PACK
Published
2022-10-05
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
OIORadiographic contrast tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIORadiographic Contrast TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594531391PackageGS12In Commercial Distribution
10195594531393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559453139150195594531391
1019559453139310195594531393

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956514379CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-27
10198956530102CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-27
10198956533295CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-27
10198956529281CARDINAL HEALTHCardinal Health 200, LLCOIO2026-07-20
10198956470156CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-08
10198956470255CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-08
10198956418813CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-03
10198956496651CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-03
10198956369665CARDINAL HEALTHCardinal Health 200, LLCOIO2026-06-01
10197106083055CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-28
10197106065778CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-17
10197106083505CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-09
10197106074954CARDINAL HEALTHCardinal Health 200, LLCOIO2022-12-15
10197106047835CARDINAL HEALTHCardinal Health 200, LLCOIO2022-12-08
10197106061169CARDINAL HEALTHCardinal Health 200, LLCOIO2022-12-06
10197106044674CARDINAL HEALTHCardinal Health 200, LLCOIO2022-11-22
10195594793869CARDINAL HEALTHCardinal Health 200, LLCOIO2022-11-04
10197106015995CARDINAL HEALTHCardinal Health 200, LLCOIO2022-11-03
10197106007341CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-28
10197106002209CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-19
10195594790141CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-18
10195594874094CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594875398CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594876098CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594880156CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-10
10195594845834CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-06
10195594835545CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-05
10195594810276CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-04
10195594827120CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-03
10195594870072CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-03