FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106013199
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-2908D
Catalog number
34-2908D
Device description
ARTHROGRAM INJECTION TRAY
Published
2023-02-17
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
OIIArthrogram tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIIArthrogram TrayRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106013197PackageGS130In Commercial Distribution
10197106013199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710601319750197106013197
1019710601319910197106013199

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 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
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
10197106030783CARDINAL HEALTHCardinal Health 200, LLCOII2023-05-23
10197106159743CARDINAL HEALTHCardinal Health 200, LLCOII2023-05-08
10197106151952CARDINAL HEALTHCardinal Health 200, LLCOII2023-04-25
10197106084434CARDINAL HEALTHCardinal Health 200, LLCOII2023-04-14
10197106093603CARDINAL HEALTHCardinal Health 200, LLCOII2023-04-07
10197106197370CARDINAL HEALTHCardinal Health 200, LLCOII2023-03-21
10197106185575CARDINAL HEALTHCardinal Health 200, LLCOII2023-03-20
10197106051030CARDINAL HEALTHCardinal Health 200, LLCOII2023-03-08
10197106102428CARDINAL HEALTHCardinal Health 200, LLCOII2023-03-06
10197106154243CARDINAL HEALTHCardinal Health 200, LLCOII2023-03-02
10197106104811CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-27
10197106098547CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-17
10197106110621CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-16
10197106123683CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-16
10197106098639CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-10
10197106107720CARDINAL HEALTHCardinal Health 200, LLCOII2023-02-07
10197106059647CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-31
10195594700218CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-30
10197106043585CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-26
10195594766542CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-20
10197106105214CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-19
10195594878801CARDINAL HEALTHCardinal Health 200, LLCOII2023-01-13
10197106061800CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-30
10195594879396CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-29
10197106073759CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-29
10197106078266CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-23
10197106038505CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-22
10197106059678CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-19
10195594835842CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-15
10197106059661CARDINAL HEALTHCardinal Health 200, LLCOII2022-12-14