FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106922514
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
41-0035D
Catalog number
41-0035D
Device description
MI FLUORO PROCEDURE TRAY
Published
2025-05-29
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
OILDiscography kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OILDiscography KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106922512PackageGS120In Commercial Distribution
10197106922514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710692251250197106922512
1019710692251410197106922514

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
10198956235823CARDINAL HEALTHCardinal Health 200, LLCOIL2025-10-23
50197106922512CARDINAL HEALTHCardinal Health 200, LLCOIL2025-05-29
10197106551417CARDINAL HEALTHCardinal Health 200, LLCOIL2024-07-16
50197106551415CARDINAL HEALTHCardinal Health 200, LLCOIL2024-07-16
10197106518984CARDINAL HEALTHCardinal Health 200, LLCOIL2024-02-07
50197106518982CARDINAL HEALTHCardinal Health 200, LLCOIL2024-02-07
10197106533628CARDINAL HEALTHCardinal Health 200, LLCOIL2024-01-17
50197106533626CARDINAL HEALTHCardinal Health 200, LLCOIL2024-01-17
B875550Discography KitCustom Interventional Pain Management, LLCOIL2023-07-19
B87555LID0Discography KitCustom Interventional Pain Management, LLCOIL2023-07-19
10888439854107CARDINAL HEALTHCardinal Health 200, LLCOIL2020-07-06
50888439854105CARDINAL HEALTHCardinal Health 200, LLCOIL2020-07-06
10888439679953CARDINAL HEALTHCardinal Health 200, LLCOIL2020-02-04
50888439679951CARDINAL HEALTHCardinal Health 200, LLCOIL2020-02-04
10888439423938CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-18
50888439423936CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-18
10888439401455CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-01
50888439401453CARDINAL HEALTHCardinal Health 200, LLCOIL2019-03-01
10888439345902CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-24
50888439345900CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-24
10888439312836CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-22
50888439312834CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-22
10888439340136CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-10
50888439340134CARDINAL HEALTHCardinal Health 200, LLCOIL2019-01-10
10888439246643CARDINAL HEALTHCardinal Health 200, LLCOIL2018-10-26
50888439246641CARDINAL HEALTHCardinal Health 200, LLCOIL2018-10-26
10887488712840CARDINAL HEALTHCardinal Health 200, LLCOIL2017-05-17
50887488712848CARDINAL HEALTHCardinal Health 200, LLCOIL2017-05-17
10887488221786CARDINAL HEALTHCardinal Health 200, LLCOIL2016-09-26
50887488221784CARDINAL HEALTHCardinal Health 200, LLCOIL2016-09-26