FDA.report

CARDINAL HEALTH

Primary DI
50195594916662
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP45SAPR1
Catalog number
SOP45SAPR1
Device description
SHOULDER ARTHROSCOPY PACK
Published
2021-01-29
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

Related Records

Product Codes

CodeName
OJHOrthopedic tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594916662PackageGS13In Commercial Distribution
10195594916664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559491666250195594916662
1019559491666410195594916664

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods

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 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 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