FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439363258
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP45OPWP4
Catalog number
SOP45OPWP4
Device description
ORTHO PACK
Published
2019-02-04
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
OJHOrthopedic tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439363256PackageGS13In Commercial Distribution
10888439363258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843936325650888439363256
1088843936325810888439363258

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain 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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101524CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956320086CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956332638CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956362147CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956371040CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956372641CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956379008CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956385689CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956391604CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956423756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956447974CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956462243CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956464957CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956465756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956467330CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956472785CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956478329CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956479630CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956481718CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956487529CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956488588CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956489981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490185CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490741CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956491007CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956491144CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492523CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492639CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492899CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03