FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439416602
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP69THHE1
Catalog number
SOP69THHE1
Device description
TOTAL HIP PACK
Published
2019-03-08
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
50888439416600PackageGS12In Commercial Distribution
10888439416602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843941660050888439416600
1088843941660210888439416602

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.

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956218611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956332096CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956343139CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956373372CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956373976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956395107CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956433984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956434677CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956435636CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956437883CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956440326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956446076CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956453661CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956455429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956460720CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956461888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956464759CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956481565CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482005CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482166CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956482425CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483279CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483620CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956483835CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484764CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956484887CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956487192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08
10198956488175CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-08