FDA.reportPublic FDA data

Halyard

Primary DI
10809160530719
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
PVHM218-02_0002
Catalog number
PVHM218-02
Published
2026-08-19
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
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
20809160530716PackageGS16In Commercial Distribution
10809160530719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053071620809160530716
1080916053071910809160530719

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, medicatedA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform an ENT surgical 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
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
10809160530696HalyardPVHM227-02_0003PVHM227-022026-08-19
10809160530702HalyardPVHM224-02_0005PVHM224-022026-08-19
10809160530726HalyardPVHM220-02_0002PVHM220-022026-08-19
10809160530733HalyardPVHM207-02_0001PVHM207-022026-08-19
10809160530740HalyardPVHM201-02_0004PVHM201-022026-08-19
10809160530757HalyardPVHM205-02_0003PVHM205-022026-08-19
10809160530764HalyardPVHM221-02_0001PVHM221-022026-08-19
10809160530771HalyardPVHM216-02_0003PVHM216-022026-08-19
10809160530788HalyardPVHM223-02_0005PVHM223-022026-08-19
10809160530795HalyardPVHM214-02_0002PVHM214-022026-08-19
10809160530801HalyardPVHM211-01_0002PVHM211-012026-08-19
10809160530818HalyardPVHM219-02_0002PVHM219-022026-08-19
10809160530825HalyardPVHM225-01_0004PVHM225-012026-08-19
10809160530832HalyardPVHM208-02_0005PVHM208-022026-08-19
10809160530894HalyardNCDS018-02_0010NCDS018-022026-08-19
10809160530900HalyardPVHM229-02_0006PVHM229-022026-08-19
10809160530252HalyardSHAN426-09_0003SHAN426-092026-08-18
10809160530269HalyardSJGH104-07_0002SJGH104-072026-08-18
10809160530276HalyardSHAN408-05_0003SHAN408-052026-08-18
10809160530283HalyardSHAN410-05_0003SHAN410-052026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160530702HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530726HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530740HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530771HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530788HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530818HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530825HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530894HalyardAVID MEDICAL, INC.LRO2026-08-19
10809160530900HalyardAVID MEDICAL, INC.LRO2026-08-19
10885632530845SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530852SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530869SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530876SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530883SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
10885632530913SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-08-19
B098AMS197320Aligned Medical SolutionsAligned Medical SolutionsLRO2026-08-19
10198956361003CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956510678CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956516915CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956542273CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956549609CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10198956555303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-08-18
10809160530276HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530283HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530306HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530313HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530320HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530344HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530351HalyardAVID MEDICAL, INC.LRO2026-08-18
10809160530368HalyardAVID MEDICAL, INC.LRO2026-08-18