FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956251915
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNU35ISCR1
Catalog number
SNU35ISCR1
Device description
INSTRUMENT SET
Published
2025-11-04
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
50198956251913PackageGS130In Commercial Distribution
10198956251915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895625191350198956251913
1019895625191510198956251915

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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

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
10198956210370CARDINAL HEALTHCardinal Health 200, LLCPXV2025-10-03
10198956137479CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956137477CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
10198956057500CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
50198956057508CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
10653160383338CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONPXV2024-12-11
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
10653160378730CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONPXV2024-08-12
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032440MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08