FDA.report

CARDINAL HEALTH

Primary DI
50195594495174
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA18BBAM5
Catalog number
SBA18BBAM5
Device description
35013, BREAST BIOPSY SOUTH
Published
2022-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MJGDEVICE, PERCUTANEOUS, BIOPSY

Product Code Classifications

CodeDeviceSpecialtyClass
MJGDevice, Percutaneous, BiopsyGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594495174PackageGS13In Commercial Distribution
10195594495176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559449517450195594495174
1019559449517610195594495176

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06974405095050CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.MJG2026-05-26
06974405095197CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.MJG2026-05-26
06974405095203CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.MJG2026-05-26
50198956384000CARDINAL HEALTHCardinal Health 200, LLCMJG2026-03-19
50198956353556CARDINAL HEALTHCardinal Health 200, LLCMJG2026-03-10
50198956281132CARDINAL HEALTHCardinal Health 200, LLCMJG2026-02-17
50198956313222CARDINAL HEALTHCardinal Health 200, LLCMJG2026-01-30
50198956317923CARDINAL HEALTHCardinal Health 200, LLCMJG2026-01-30
50198956290929CARDINAL HEALTHCardinal Health 200, LLCMJG2026-01-23
50198956239157CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-26
50198956217247CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-23
50198956295085CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-19
50198956233445CARDINAL HEALTHCardinal Health 200, LLCMJG2025-12-11
50198956256048CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-28
50198956268348CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-28
50198956201147CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-25
50198956221695CARDINAL HEALTHCardinal Health 200, LLCMJG2025-11-11
50198956140958CARDINAL HEALTHCardinal Health 200, LLCMJG2025-09-29
50198956133592CARDINAL HEALTHCardinal Health 200, LLCMJG2025-08-28
04048223128954PrimoCutPajunk GmbH MedizintechnologieMJG2025-07-30
50198956127553CARDINAL HEALTHCardinal Health 200, LLCMJG2025-07-15
04048223128893PrimoCutPajunk GmbH MedizintechnologieMJG2025-06-17
04048223128947Coaxial sleeve Ø 1,50 (17G)Pajunk GmbH MedizintechnologieMJG2025-06-17
04048223131923Coaxial sleeve Ø 1,50 (17G)Pajunk GmbH MedizintechnologieMJG2025-06-17
50198956116564CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-16
50198956084092CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-11
50197106926800CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
50197106927999CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-10
50198956017533CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05
50198956033540CARDINAL HEALTHCardinal Health 200, LLCMJG2025-06-05