FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106056974
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP53ATVL5
Catalog number
SOP53ATVL5
Device description
ARTHROSCOPY 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
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
50197106056972PackageGS13In Commercial Distribution
10197106056974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710605697250197106056972
1019710605697410197106056974

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17809A0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-22
10809160527603HALYARDAVID MEDICAL, INC.OJH2026-07-21
10198956180222CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956282360CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956291836CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956301573CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956307438CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956316515CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956338326CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956362208CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370456CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956370982CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956372559CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956378421CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956379077CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956383302CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956387201CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956391673CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956392823CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956402676CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956416116CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956422506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956440869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956442290CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956455115CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460775CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956460874CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956461994CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956463110CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20
10198956463127CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20