FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956530102
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN73NIKSG
Catalog number
SAN73NIKSG
Device description
NIR PACK
Published
2026-07-27
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
OIORadiographic contrast tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIORadiographic Contrast TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956530100PackageGS12In Commercial Distribution
10198956530102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653010050198956530100
1019895653010210198956530102

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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 Temperature00

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
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19
10198956519527CARDINAL HEALTH17-7678I17-7678I2026-10-19
10198956519756CARDINAL HEALTHPO33UEVWBPO33UEVWB2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956588202CARDINAL HEALTHCardinal Health 200, LLCOIO2026-10-19
10198956598430CARDINAL HEALTHCardinal Health 200, LLCOIO2026-10-19
10198956611726CARDINAL HEALTHCardinal Health 200, LLCOIO2026-10-19
10198956556836CARDINAL HEALTHCardinal Health 200, LLCOIO2026-10-12
10198956340268CARDINAL HEALTHCardinal Health 200, LLCOIO2026-10-06
10198956580855CARDINAL HEALTHCardinal Health 200, LLCOIO2026-09-22
10198956514379CARDINAL 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
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
10195594531393CARDINAL HEALTHCardinal Health 200, LLCOIO2022-10-05
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