FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594354532
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-0729A
Catalog number
32-0729A
Device description
BIOPSY KIT
Published
2021-10-31
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
POZBiopsy needle kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POZBiopsy Needle KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594354532PackageGS112In Commercial Distribution
10195594354534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559435453250195594354532
1019559435453410195594354534

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
16931918144559InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
16931918163949InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
26931918144556InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
26931918163946InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2024-02-02
16931918148892InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2023-10-20
26931918148899InvenioGRI Medical & Electronic Technology Co., Ltd.POZ2023-10-20
10195594354534CARDINAL HEALTHCardinal Health 200, LLCPOZ2021-10-31
00857878007255ASK-1 Aspiration Starter KitRANFAC CORP.POZ2018-03-07
20857878007259ASK-1 Aspiration Starter KitRANFAC CORP.POZ2018-03-07
00815277022057CuraplexBOUND TREE MEDICAL, LLCPOZ2016-12-14