FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594555108
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-3841A
Catalog number
32-3841A
Device description
OPP8 BREAST BIOPSY KIT
Published
2022-04-05
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
50195594555106PackageGS110In Commercial Distribution
10195594555108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559455510650195594555106
1019559455510810195594555108

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197106981917CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-07