FDA.reportPublic FDA data

Halyard

Primary DI
20809160349622
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VAOR020-07_0001
Catalog number
VAOR020-07
Published
2021-04-26
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
20809160349622PackageGS12In Commercial Distribution
10809160349625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916034962220809160349622
1080916034962510809160349625

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.

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
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
10198459760846MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-09-25
10198956172715CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956339729CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956393288CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956461086CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956462205CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956511286CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956520608CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956534308CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956541931CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956549357CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956551541CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956552791CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956554047CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956558700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956561007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956561038CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565425CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956565647CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956567788CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568211CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568426CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956568433CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956569379CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956572522CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573734CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573789CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956573857CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956574366CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25
10198956576568CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-25