FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439337341
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PE3KHNCAA
Catalog number
PE3KHNCAA
Device description
KIT, HEAD AND NECK SPLIT SHEET
Published
2019-02-06
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
50888439337349PackageGS12In Commercial Distribution
10888439337341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843933734950888439337349
1088843933734110888439337341

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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160523063HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523070HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523094HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523100HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523124HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523131HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523223HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523230HalyardAVID MEDICAL, INC.LRO2026-06-09
10809160523247HalyardAVID MEDICAL, INC.LRO2026-06-09
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