FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956370982
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP56LEOSH
Catalog number
SOP56LEOSH
Device description
LOWER EXTREMITY PACK
Published
2026-07-20
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
50198956370980PackageGS12In Commercial Distribution
10198956370982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895637098050198956370980
1019895637098210198956370982

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.

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
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
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
10198956465596CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-20