FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956015722
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-2907F
Catalog number
32-2907F
Device description
BREAST BIOPSY TRAY
Published
2025-05-09
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
MJGDevice, percutaneous, biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956015720PackageGS150In Commercial Distribution
10198956015722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895601572050198956015720
1019895601572210198956015722

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956511699CARDINAL HEALTHCardinal Health 200, LLCMJG2026-07-06
10198956133594CARDINAL HEALTHCardinal Health 200, LLCMJG2025-08-28
10198956127555CARDINAL HEALTHCardinal Health 200, LLCMJG2025-07-15
10198956116566CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-16
10198956084094CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-11
10197106926802CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
10197106927991CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
10198956017535CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956033542CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956078932CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-22
10198956010109CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-17
10198956040342CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-09
10198956001718CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-07
10197106850770CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-01
10198956024380CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-01
10197106838501CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-20
10197106980699CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-20
10197106983744CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-11
10197106963715CARDINAL HEALTHCardinal Health 200, LLCMJG2025-03-06
10197106917138CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-28
10197106962107CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-28
10197106933343CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-26
10197106945278CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-25
10197106910887CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-12
10197106924686CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-10
10197106924013CARDINAL HEALTHCardinal Health 200, LLCMJG2025-02-04
10197106802342CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106914250CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-30
10197106905951CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-17
10197106887622CARDINAL HEALTHCardinal Health 200, LLCMJG2025-01-15