FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594660260
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
41-7717A
Catalog number
41-7717A
Device description
IR BIOPSY TRAY
Published
2022-06-21
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
OIJBiopsy needle guide kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIJBiopsy Needle Guide KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594660268PackageGS124In Commercial Distribution
10195594660260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559466026850195594660268
1019559466026010195594660260

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
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.OIJ2026-05-11
06945868600471SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603809SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603816SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603823SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603830SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603847SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603878SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605872SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605889SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605896SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605902SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605919SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605926SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605933SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605940SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605957SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605964SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605971SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605988SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605995SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606008SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606015SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606022SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606039SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606046SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606053SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606060SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606077SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606084SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09