FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594006075
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP11LIS11
Catalog number
SOP11LIS11
Device description
LIGAMENT REPAIR PACK
Published
2021-04-06
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
50195594006073PackageGS11In Commercial Distribution
10195594006075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559400607350195594006073
1019559400607510195594006075

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 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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956333901CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956530645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956537262CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956539563CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956542631CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956558915CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956559608CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956560147CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562592CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956562967CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956563018CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956566880CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956567771CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956568976CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956569256CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956570900CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956571549CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956580091CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956582941CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956587373CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592353CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592735CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956592865CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956593695CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956596443CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-30
10198956356122CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29
10198956474888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-29