FDA.reportPublic FDA data

HALYARD

Primary DI
10809160527887
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
PVHM205-02
Catalog number
PVHM205-02
Published
2026-07-28
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
20809160527884PackageGS13In Commercial Distribution
10809160527887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052788420809160527884
1080916052788710809160527887

GMDN Terms#

Term, Definition table
TermDefinition
Craniotomy kitA collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160539002HalyardMAMC223-14_0003MAMC223-142026-09-25
10809160539040HalyardEURO005-09_0005EURO005-092026-09-25
10809160539057HalyardEURO003-10_0005EURO003-102026-09-25
10809160539064HalyardEURO003-11_0002EURO003-112026-09-25
10809160539071HalyardEURO005-10_0002EURO005-102026-09-25
10809160539088HalyardEURO006-10_0002EURO006-102026-09-25
10809160539095HalyardEURO006-09_0001EURO006-092026-09-25
10809160539101HalyardHVBM205-04_0005HVBM205-042026-09-25
10809160539118HalyardWINN117-05_0014WINN117-052026-09-25
10809160538920HALYARDBPEN95-02BPEN95-022026-09-24
10809160538944HalyardMAMC221-16_0031MAMC221-162026-09-24
10809160538951HalyardJACK410-11_0008JACK410-112026-09-24
10809160538975HalyardWBAM044-04_0003WBAM044-042026-09-24
10809160538982HalyardSWMR007-04_0008SWMR007-042026-09-24
10809160538586HalyardGBDV49-02_0011GBDV49-022026-09-22
10809160538593HalyardBPTJ33-02_0019BPTJ33-022026-09-22
10809160538616HalyardHVBM201-06_0005HVBM201-062026-09-22
10809160538623HalyardSAMM018-14_0005SAMM018-142026-09-22
10809160538630HalyardLVMN12-02_0009LVMN12-022026-09-22
10809160538647HalyardWRNM015-12_0006WRNM015-122026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS14766C0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-09-26
10198956466838CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956497382CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956502604CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956513143CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956553910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956559752CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956565616CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956567818CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956568549CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956579194CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956581746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956582378CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956584662CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956585751CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956586895CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587335CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587663CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956587724CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956588431CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956588622CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956589797CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956589995CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590021CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590250CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10198956590366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-25
10809160538951HalyardAVID MEDICAL, INC.OJG2026-09-24
10198956313897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956488366CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22
10198956489196CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-22