FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956066753
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
36-0891C
Catalog number
36-0891C
Device description
PCI PACK
Published
2025-08-27
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
50198956066753PackageGS140In Commercial Distribution
10198956066755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895606675350198956066753
1019895606675510198956066755

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.

Sterilization Methods#

Method table
Method

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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106115121CARDINAL HEALTHCardinal Health 200, LLCOIO2023-03-13
10197106140246CARDINAL HEALTHCardinal Health 200, LLCOIO2023-02-21
10197106105429CARDINAL HEALTHCardinal Health 200, LLCOIO2023-02-16
10197106115312CARDINAL HEALTHCardinal Health 200, LLCOIO2023-02-16
10197106105771CARDINAL HEALTHCardinal Health 200, LLCOIO2023-02-01
10197106083055CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-28
10197106065778CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-17
10197106099049CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-17
10197106083505CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-09
10197106088487CARDINAL HEALTHCardinal Health 200, LLCOIO2023-01-09
10197106090299CARDINAL HEALTHCardinal Health 200, LLCOIO2022-12-30
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
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