FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594017224
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
OVCHF4462A
Catalog number
OVCHF4462A
Device description
KIT, INJECTION
Published
2021-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594017222PackageGS125In Commercial Distribution
10195594017224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559401722250195594017222
1019559401722410195594017224

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219289043LANDANGERLANDANGERLRP2026-09-27
10198956383043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956535428CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956589193CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956590267CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956590304CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956591554CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956592216CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956592827CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956593336CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956594555CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595118CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595125CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595613CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956595804CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956596108CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956596115CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956596184CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597488CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597501CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597839CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956597969CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
10198956598836CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-25
00816611026649AngioSystems TrayANGIOSYSTEMS, INCORPORATEDLRP2026-09-22
10198956446953CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956486294CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956520240CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956570191CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578371CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22
10198956578401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-22