FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106663707
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PNHFBKAACE
Catalog number
PNHFBKAACE
Device description
KIT, BACK
Published
2024-06-18
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
50197106663705PackageGS11In Commercial Distribution
10197106663707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710666370550197106663705
1019710666370710197106663707

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. 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