FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885425299902
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNU43BSSPE
Catalog number
SNU43BSSPE
Device description
STERILE NEEDLE CORE BIOPSY PK
Published
2016-06-27
Public version status
Update
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
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
50885425299902PackageGS110In Commercial Distribution
10885425299904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542529990250885425299902
1088542529990410885425299904

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
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