FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106367612
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP11AKS15
Catalog number
SOP11AKS15
Device description
ARTHROSCOPY KNEE PACK
Published
2023-07-13
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106367610PackageGS12In Commercial Distribution
10197106367612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710636761050197106367610
1019710636761210197106367612

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments, dressings, pharmaceuticals, and the necessary materials used to perform an arthroscopic surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
B098AMS186950Aligned Medical SolutionsAligned Medical SolutionsOJH2026-08-03
10198956372849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956423824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956439429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956483613CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956495333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956497849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956500150CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503106CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956506824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512566CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956516076CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956518728CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521230CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523777CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523838CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956529601CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956532380CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533455CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533868CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534216CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534445CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534995CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956535138CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31