FDA.reportPublic FDA data

Halyard

Primary DI
10809160528129
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
NAMC434-09_0002
Catalog number
NAMC434-09
Published
2026-07-30
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160528126PackageGS12In Commercial Distribution
10809160528129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052812620809160528126
1080916052812910809160528129

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical procedure kit, medicatedA collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
10809160528112HalyardSAMM041-08_0001SAMM041-082026-07-30
10809160528136HalyardNAFB062-09_0001NAFB062-092026-07-30
10809160528143HalyardGBEY17-02_0011GBEY17-022026-07-30
10809160528150HalyardPVHM222-02_0005PVHM222-022026-07-30
10809160528167HalyardSBHT00-06_0001SBHT00-062026-07-30
10809160528174HalyardDONS101-02_0001DONS101-022026-07-30
10809160528181HalyardQCEORSP123_0001QCEORSP1232026-07-30
10809160528198HalyardVMLR032-04_0005VMLR032-042026-07-30
10809160528051HalyardBPTJ33-01_0016BPTJ33-012026-07-29
10809160528075HalyardBMHT301-02_0007BMHT301-022026-07-29
10809160528082HalyardWINN121-11_0004WINN121-112026-07-29
10809160528099HalyardJCSP60F_0011JCSP60F2026-07-29
10809160528105HalyardESEY90-03_0016ESEY90-032026-07-29
10809160527856HalyardAVMD054_0004AVMD0542026-07-28
10809160527863HalyardAVMD052-02_0004AVMD052-022026-07-28
10809160527870HALYARDPVHM201-02PVHM201-022026-07-28
10809160527887HALYARDPVHM205-02PVHM205-022026-07-28
10809160527894HalyardOGDV68-02OGDV68-022026-07-28
10809160527900HalyardUPVD01-02UPVD01-022026-07-28
10809160527924HALYARDPVHM208-02PVHM208-022026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527887HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527924HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160527986HALYARDAVID MEDICAL, INC.OJG2026-07-28
10809160528013HalyardAVID MEDICAL, INC.OJG2026-07-28
10809160528037HalyardAVID MEDICAL, INC.OJG2026-07-28
10197106927687CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956337404CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956416444CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956479364CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480698CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956480919CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956494626CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956500075CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956502611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956505605CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956510876CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956513204CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956514911CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956516380CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956520066CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956520714CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956524019CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956529700CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956532427CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956532755CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956534285CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956534339CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956534353CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956537071CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27
10198956538436CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-27