FDA.report

CARDINAL HEALTH

Primary DI
50197106933341
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-0891B
Catalog number
32-0891B
Device description
BRISTOL BREAST BIOPSY PACK
Published
2025-02-26
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
50197106933341PackageGS112In Commercial Distribution
10197106933343PrimaryGS10

GMDN Terms

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

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
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
50198956015720CARDINAL HEALTHCardinal Health 200, LLCMJG2025-05-09
50198956010107CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-17
50198956040340CARDINAL HEALTHCardinal Health 200, LLCMJG2025-04-09