FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956534490
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PU13CPAJE
Catalog number
PU13CPAJE
Device description
KIT, CYSTO
Published
2026-10-29
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
50198956534498PackageGS13In Commercial Distribution
10198956534490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653449850198956534498
1019895653449010198956534490

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
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29
10198956513310CARDINAL HEALTHSOP23SACACSOP23SACAC2026-10-29
10198956517240CARDINAL HEALTHSOP31KAOSXSOP31KAOSX2026-10-29
10198956521032CARDINAL HEALTHSENCGTACPCSENCGTACPC2026-10-29
10198956531932CARDINAL HEALTHSBA8CBPSPBSBA8CBPSPB2026-10-29
10198956533592CARDINAL HEALTHSAN42PMTMPSAN42PMTMP2026-10-29
10198956533653CARDINAL HEALTHSCV4AAAJHVSCV4AAAJHV2026-10-29
10198956535633CARDINAL HEALTHSOPMIEPMAFSOPMIEPMAF2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956359888CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956428195CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956513310CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956517240CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956535633CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956548886CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956550865CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956553712CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956557994CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956568402CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956572133CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956576995CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956581333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956584136CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956586819CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956586857CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956592100CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956592339CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956594609CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956594661CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956594913CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956596290CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956596313CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956599796CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956600225CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956600249CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956603431CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956604582CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956604919CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29
10198956607514CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-29