FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956057500
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA4JLPUNC
Catalog number
SBA4JLPUNC
Device description
PK INST LAP CHOLE UN UW AN
Published
2025-06-05
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
PXVGeneral purpose instrument tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXVGeneral Purpose Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956057508PackageGS12In Commercial Distribution
10198956057500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895605750850198956057508
1019895605750010198956057500

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.

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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
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
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956281660CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
50198956281668CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
10198956244580CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
50198956244588CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
10198956251915CARDINAL HEALTHCardinal Health 200, LLCPXV2025-11-04
10198956210370CARDINAL HEALTHCardinal Health 200, LLCPXV2025-10-03
10198956137479CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956137477CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956057508CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
00843356102741CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102758CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102765CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102772CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102789CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
00843356102796CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102744CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102751CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102768CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102775CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102782CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102799CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
10197106773284CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
50197106773282CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
00843356102819CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102826CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102833CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032440MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032457MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032464MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08