FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956359147
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP54FPEVC
Catalog number
SOP54FPEVC
Device description
FOOT PACK
Published
2026-09-21
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
50198956359145PackageGS14In Commercial Distribution
10198956359147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895635914550198956359145
1019895635914710198956359147

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.

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556839690Total Foot System 2Smith & Nephew, Inc.OJH2026-09-24
00885556839706Total Foot System 2Smith & Nephew, Inc.OJH2026-09-24
00885556859636Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859643Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859650Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859698Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859704Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859711Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859728Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859735Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859742Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859759Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859766Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859773Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859780Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859797Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
00885556859803Titan Modular Shoulder SystemSmith & Nephew, Inc.OJH2026-09-24
10198956362550CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956415607CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956462984CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956502468CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956507654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956513365CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956520257CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956533264CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956538214CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956545618CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956545687CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956552005CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22
10198956552203CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-22