FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106549971
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP53KALKA
Catalog number
SOP53KALKA
Device description
KNEE ARTHRO PACK
Published
2024-02-12
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
OMAAmplitude-integrated electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMAAmplitude-Integrated ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106549979PackageGS14In Commercial Distribution
10197106549971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710654997950197106549979
1019710654997110197106549971

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. 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
00850056774017NeuroMatchLVIS CORPORATIONOMA2026-05-12
09120109830269encevisAIT Austrian Institute of Technology GmbHOMA2025-08-05
00850056774000NeuroMatchLVIS CORPORATIONOMA2025-04-04
00382830057745XltekXLTEKOMA2024-04-19
00382830061902XltekXLTEKOMA2024-04-19
50197106549979CARDINAL HEALTHCardinal Health 200, LLCOMA2024-02-12
00382830063067XltekXLTEKOMA2023-08-23
B485CNSENV1000CNS EnvisionNATUS NEUROLOGY INCORPORATEDOMA2023-08-18
00382830062947Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062954Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062961Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830062985Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063005Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063012Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830063029Component Neuromonitoring SystemNATUS NEUROLOGY INCORPORATEDOMA2023-08-14
00382830059541XltekXLTEKOMA2023-07-26
00382830061742XltekXLTEKOMA2023-07-26
00382830061766XltekXLTEKOMA2023-07-26
00869732000166Persyst 15 EEG Review and Analysis SoftwarePersyst Development CorpOMA2023-07-24
09120109830122encevisAIT Austrian Institute of Technology GmbHOMA2022-07-15
00382830008679NatusXLTEKOMA2021-10-26
00382830007450NatusXLTEKOMA2021-10-07
00382830007443NatusXLTEKOMA2021-10-07
00382830058209NatusXLTEKOMA2021-04-20
00382830058216NatusXLTEKOMA2021-04-20
00382830058575NatusXLTEKOMA2021-04-20
B485CNSPTZ3501Component Monitoring SystemMOBERG RESEARCH INCOMA2021-04-19
B485CNS3501Component Neuromonitoring SystemMOBERG RESEARCH INCOMA2021-02-12
09120109830078encevisAIT Austrian Institute of Technology GmbHOMA2021-01-11
B485CNSVID3501Component Monitoring SystemMOBERG RESEARCH INCOMA2020-10-31