FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956346833
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-5605E
Catalog number
32-5605E
Device description
HRZ BREAST BIOPSY TRAY
Published
2026-03-02
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
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
50198956346831PackageGS112In Commercial Distribution
10198956346833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895634683150198956346831
1019895634683310198956346833

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
10192253031782DoverP4P16CSDP4P16CSD2026-06-18
10197106959497CARDINAL HEALTHSOP40TKSSBSOP40TKSSB2026-08-17
10198956289475CARDINAL HEALTHANECG1739KANECG1739K2026-08-17
10198956377691CARDINAL HEALTHSOPDKOPASBSOPDKOPASB2026-08-17
10198956384767CARDINAL HEALTHSBAOCPS24BSBAOCPS24B2026-08-17
10198956394773CARDINAL HEALTH34-5117B34-5117B2026-08-17
10198956406964CARDINAL HEALTHSMA11VLMMLSMA11VLMML2026-08-17
10198956416598CARDINAL HEALTHSEN11EPHLJSEN11EPHLJ2026-08-17
10198956427020CARDINAL HEALTHSMA13GPBTBSMA13GPBTB2026-08-17
10198956442399CARDINAL HEALTHSOP13HPOSBSOP13HPOSB2026-08-17
10198956442436CARDINAL HEALTHSOP13TJOSBSOP13TJOSB2026-08-17
10198956472945CARDINAL HEALTHSOP29TIWCLSOP29TIWCL2026-08-17
10198956475090CARDINAL HEALTHSEY13EYBIWSEY13EYBIW2026-08-17
10198956494800CARDINAL HEALTHSAN45RMIMBSAN45RMIMB2026-08-17
10198956498419CARDINAL HEALTHSMA63HYWPESMA63HYWPE2026-08-17
10198956499348CARDINAL HEALTH03E2340C03E2340C2026-08-17
10198956500372CARDINAL HEALTHSBA40TPEAESBA40TPEAE2026-08-17
10198956500501CARDINAL HEALTHSCV12VPUVGSCV12VPUVG2026-08-17
10198956501799CARDINAL HEALTHSENCGTYRIGSENCGTYRIG2026-08-17
10198956505780CARDINAL HEALTHSMAHDGLMJGSMAHDGLMJG2026-08-17

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
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
10197106981917CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-07