FDA.report

CARDINAL HEALTH

Primary DI
50197106665006
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
32-5841A
Catalog number
32-5841A
Device description
BREAST BIOPSY TRAY
Published
2024-06-15
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
PXPBreast biopsy / localization tray

Product Code Classifications

CodeDeviceSpecialtyClass
PXPBreast Biopsy / Localization TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106665006PackageGS145In Commercial Distribution
10197106665008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710666500650197106665006
1019710666500810197106665008

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

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10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956346831CARDINAL HEALTHCardinal Health 200, LLCPXP2026-03-02
50198956340341CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-17
50197106922505CARDINAL HEALTHCardinal Health 200, LLCPXP2026-02-09
50198956291407CARDINAL HEALTHCardinal Health 200, LLCPXP2026-01-15
50198956287943CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956294927CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-12
50198956239423CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-11
50198956259988CARDINAL HEALTHCardinal Health 200, LLCPXP2025-12-02
50198956260915CARDINAL HEALTHCardinal Health 200, LLCPXP2025-11-28
50198956190861CARDINAL HEALTHCardinal Health 200, LLCPXP2025-09-09
50198956155617CARDINAL HEALTHCardinal Health 200, LLCPXP2025-08-27
50198956129250CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-24
50198956119138CARDINAL HEALTHCardinal Health 200, LLCPXP2025-07-21
50197106928682CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-11
50197106981915CARDINAL HEALTHCardinal Health 200, LLCPXP2025-03-07
50197106923281CARDINAL HEALTHCardinal Health 200, LLCPXP2025-01-23
00653160384895MEDLINEMEDLINE INDUSTRIES, INC.PXP2025-01-23
00653160384123MEDLINEMEDLINE INDUSTRIES, INC.PXP2025-01-13
00884838127609DUNLEE SENTINELLEPhilips Medical Systems Nederland B.V.PXP2025-01-10
00884838119451Philips SentinellePhilips Medical Systems Nederland B.V.PXP2024-12-17
00884838119468Philips SentinellePhilips Medical Systems Nederland B.V.PXP2024-12-17
50197106827534CARDINAL HEALTHCardinal Health 200, LLCPXP2024-11-25
50197106743933CARDINAL HEALTHCardinal Health 200, LLCPXP2024-09-13
00653160378153MEDLINEMEDLINE INDUSTRIES, INC.PXP2024-07-29
00884838118768PhilipsPhilips Medical Systems Nederland B.V.PXP2024-07-18
00884838118775PhilipsPhilips Medical Systems Nederland B.V.PXP2024-07-18
00884838118782PhilipsPhilips Medical Systems Nederland B.V.PXP2024-07-18
50197106652532CARDINAL HEALTHCardinal Health 200, LLCPXP2024-06-04
50197106584253CARDINAL HEALTHCardinal Health 200, LLCPXP2024-03-21
50197106523719CARDINAL HEALTHCardinal Health 200, LLCPXP2024-01-24