FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439416015
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PGV2HN104
Catalog number
PGV2HN104
Device description
KIT,MAJOR HEAD AND NECK
Published
2019-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439416013PackageGS11In Commercial Distribution
10888439416015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843941601350888439416013
1088843941601510888439416015

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106911266CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956359024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956364783CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956429666CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956432048CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956433144CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956443518CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956466012CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956467484CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469204CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956469624CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956473423CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477292CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956477339CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483378CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956483903CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956484368CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956487406CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956492660CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956493667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956495371CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496170CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496507CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496705CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496781CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956496835CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956497122CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08
10198956498884CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-08