FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956610712
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP48ASIW2
Catalog number
SOP48ASIW2
Device description
ASC SHOULDER PACK
Published
2026-10-15
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
50198956610710PackageGS12In Commercial Distribution
10198956610712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895661071050198956610710
1019895661071210198956610712

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 Temperature00

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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956538030CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956546424CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956555211CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956561311CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956570177CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956572157CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956572263CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956588912CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956593152CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956594388CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956596894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956597884CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956598133CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956603943CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956604544CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956605022CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
B098AMS14856B0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-14
10198956537798CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956539914CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956545182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956549050CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956563223CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956276437CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956301719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956333611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956361041CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956384439CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956388376CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956519541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956530782CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12