FDA.reportPublic FDA data

Halyard

Primary DI
20809160431594
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
PANJ003-02_0014
Catalog number
PANJ003-02
Published
2024-08-03
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

Contact Domains#

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
20809160431594PackageGS16In Commercial Distribution
10809160431597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916043159420809160431594
1080916043159710809160431597

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160522820HalyardSFSJACK455-05_0002SFSJACK455-052026-06-08
10809160522837HalyardSFSBMHU003-05_0001SFSBMHU003-052026-06-08
10809160522844HalyardSFSJACK435-09_0001SFSJACK435-092026-06-08
10809160522851HalyardBMHU003-05_0001BMHU003-052026-06-08
10809160522868HalyardSFSMSBM022-06_0001SFSMSBM022-062026-06-08
10809160522875HalyardMSBM030-06_0007MSBM030-062026-06-08
10809160522882HalyardMSBM022-06_0006MSBM022-062026-06-08
10809160522899HalyardJACK435-09_0005JACK435-092026-06-08
10809160522905HalyardSFSMSBM030-06_0002SFSMSBM030-062026-06-08
10809160522912HalyardJACK455-05_0001JACK455-052026-06-08
10809160522929HalyardSFSJCLC12-01_0001SFSJCLC12-012026-06-08
10809160522936HalyardSHAN453-04_0015SHAN453-042026-06-08
10809160522943HalyardBMHT030-05_0003BMHT030-052026-06-08
10809160522950HalyardMAMC229-22_0001MAMC229-222026-06-08
10809160522967HalyardACTK56-03_0008ACTK56-032026-06-08
10809160522974HalyardDGAL24-03_0007DGAL24-032026-06-08
10809160522981HalyardAVMD016-02_0005AVMD016-022026-06-08
10809160522998HalyardMEHY02O_0011MEHY02O2026-06-08
10809160523001HalyardMCBP83-02_0005MCBP83-022026-06-08
10809160523018HalyardMAMC213-09_0004MAMC213-092026-06-08

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