FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594354534
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
Update
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
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 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
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
50195594354532CARDINAL 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