FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956196308
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PO44KLCSD
Catalog number
PO44KLCSD
Device description
KIT, LOWER EXTREMITY
Published
2026-11-05
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
50198956196306PackageGS11In Commercial Distribution
10198956196308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895619630650198956196306
1019895619630810198956196308

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
10192253005820Monoject8602U8602U2026-11-05
10192253005837Monoject8605U8605U2026-11-05
10192253005844Monoject8607U8607U2026-11-05
10192253005851Monoject8611U8611U2026-11-05
10192253005868Monoject8612U8612U2026-11-05
10192253043112Argyle888830160688883016062026-08-12
10192253043136Argyle888830161488883016142026-08-12
10192253043143Argyle888830162288883016222026-08-12
10192253043181Argyle888830171388883017132026-08-12
10192253043198Argyle888830172188883017212026-08-12
10198956202214CARDINAL HEALTHSBA11BCNMNSBA11BCNMN2026-11-05
10198956270817CARDINAL HEALTHSOP38THBADSOP38THBAD2026-11-05
10198956341296CARDINAL HEALTHSOPDKATCH7SOPDKATCH72026-11-05
10198956346659CARDINAL HEALTHPNV2LMA01CPNV2LMA01C2026-11-05
10198956347021CARDINAL HEALTHSCV5DOVFANSCV5DOVFAN2026-11-05
10198956377486CARDINAL HEALTHSOP42AAJCGSOP42AAJCG2026-11-05
10198956390423CARDINAL HEALTHSOP34ARBCLSOP34ARBCL2026-11-05
10198956391123CARDINAL HEALTHSBAX3FFOHASBAX3FFOHA2026-11-05
10198956391666CARDINAL HEALTHSEY69BPZEBSEY69BPZEB2026-11-05
10198956392212CARDINAL HEALTHSOPW1KAERBSOPW1KAERB2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956270817CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956341296CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956377486CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956390423CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956392212CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956407923CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956426092CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956442481CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956488014CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956494398CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956498044CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956502338CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956519107CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956519497CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956519596CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956523388CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956534780CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956542396CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956545656CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956550247CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956553453CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956554023CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956554702CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956556430CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956557871CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956558052CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956558083CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956559622CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956559707CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05
10198956560123CARDINAL HEALTHCardinal Health 200, LLCOJH2026-11-05