FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594302887
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNU21BBR16
Catalog number
SNU21BBR16
Device description
BREAST CORE BIOPSY II
Published
2021-09-16
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
PXPBreast biopsy / localization tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXPBreast Biopsy / Localization TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594302885PackageGS120In Commercial Distribution
10195594302887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559430288550195594302885
1019559430288710195594302887

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956528314CARDINAL HEALTHCardinal Health 200, LLCPXP2026-07-09
10198956201804CARDINAL HEALTHCardinal Health 200, LLCPXP2026-06-01
10198956346833CARDINAL HEALTHCardinal Health 200, LLCPXP2026-03-02
50198956346831CARDINAL HEALTHCardinal Health 200, LLCPXP2026-03-02
10198956340343CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-17
50198956340341CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-17
10197106922507CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-09
50197106922505CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-09
10198956291409CARDINAL HEALTHCardinal Health 200, LLCPXP2026-01-15
50198956291407CARDINAL HEALTHCardinal Health 200, LLCPXP2026-01-15
10198956287945CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
10198956294929CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956287943CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956294927CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
10198956239425CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-11
50198956239423CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-11
10198956259980CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-02
50198956259988CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-02
10198956260917CARDINAL HEALTHCardinal Health 200, LLCPXP2025-11-28
50198956260915CARDINAL HEALTHCardinal Health 200, LLCPXP2025-11-28
10198956190863CARDINAL HEALTHCardinal Health 200, LLCPXP2025-09-09
50198956190861CARDINAL HEALTHCardinal Health 200, LLCPXP2025-09-09
10198956155619CARDINAL HEALTHCardinal Health 200, LLCPXP2025-08-27
50198956155617CARDINAL HEALTHCardinal Health 200, LLCPXP2025-08-27
10198956129252CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-24
50198956129250CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-24
10198956119130CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-21
50198956119138CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-21
10197106928684CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-11
50197106928682CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-11