FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106551415
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
41-0035C
Catalog number
41-0035C
Device description
FLUORO PROCEDURE TRAY
Published
2024-07-16
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
OILDiscography kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OILDiscography KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106551415PackageGS120In Commercial Distribution
10197106551417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710655141550197106551415
1019710655141710197106551417

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

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956235823CARDINAL HEALTHCardinal Health 200, LLCOIL2025-10-23
10197106922514CARDINAL HEALTHCardinal Health 200, LLCOIL2025-05-29
50197106922512CARDINAL HEALTHCardinal Health 200, LLCOIL2025-05-29
10197106551417CARDINAL 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