FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106032051
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP5CSPSTH
Catalog number
SOP5CSPSTH
Device description
SHOULDER PACK
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50197106032051PackageGS12In Commercial Distribution
10197106032053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710603205150197106032051
1019710603205310197106032053

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956056497CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956221161CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956253773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956257610CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956291812CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956321632CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956325487CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956354517CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956358904CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956369955CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379190CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956379381CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956382763CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956387492CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956387799CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956392465CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956399464CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956400818CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956401136CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956404151CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956414891CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956425811CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956432987CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956434752CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956437869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956442351CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956442634CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956448339CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956457980CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25
10198956457997CARDINAL HEALTHCardinal Health 200, LLCOJH2026-05-25