FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106963715
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN18BBAM1
Catalog number
SAN18BBAM1
Device description
35013, BREAST BIOPSY SOUTH PK
Published
2025-03-06
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
50197106963713PackageGS13In Commercial Distribution
10197106963715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710696371350197106963713
1019710696371510197106963715

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

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
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
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