FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106927991
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-9610F
Catalog number
32-9610F
Device description
STEREOTACTIC BREAST BIOPSY KIT
Published
2025-06-10
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
50197106927999PackageGS114In Commercial Distribution
10197106927991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710692799950197106927999
1019710692799110197106927991

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.

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

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
10198956017535CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956033542CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
10198956078932CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-22
10198956015722CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-09
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