FDA.reportPublic FDA data

Halyard

Primary DI
20809160302917
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VARV047-01_0010
Catalog number
VARV047-01
Published
2020-12-08
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
20809160302917PackageGS120In Commercial Distribution
10809160302910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916030291720809160302917
1080916030291010809160302910

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
10809160532676HalyardMSBS14-05_0006MSBS14-052026-09-04
10809160532683HalyardMSTK53-06_0002MSTK53-062026-09-04
10809160532690HalyardMSCS51-06_0005MSCS51-062026-09-04
10809160532706HalyardSFSBPAR65-02_0003SFSBPAR65-022026-09-04
10809160532713HalyardBPAR65-02_0002BPAR65-022026-09-04
10809160532737HalyardFBCH103-07_0015FBCH103-072026-09-04
10809160532744HalyardMSTK53-07_0001MSTK53-072026-09-04
10809160532768HalyardBKAP27-03_0006BKAP27-032026-09-04
10809160532775HalyardEURO053-02_0003EURO053-022026-09-04
10809160532782HalyardKAFB008-10_0016KAFB008-102026-09-04
10809160532799HalyardWRNM019-16_0003WRNM019-162026-09-04
10809160532805HalyardNAMC436-13_0007NAMC436-132026-09-04
10809160532812HalyardNAMC433-07_0008NAMC433-072026-09-04
10809160532829HalyardWRNM025-12_0005WRNM025-122026-09-04
10809160532836HalyardEAMC1000-05AUX2_0002EAMC1000-05AUX22026-09-04
10809160532843HalyardWRNM007-18_0003WRNM007-182026-09-04
10809160532850HalyardNAMC474-06_0004NAMC474-062026-09-04
10809160532867HalyardBAAK106-15_0002BAAK106-152026-09-04
10809160532874HalyardKAFB009-16_0004KAFB009-162026-09-04
10809160532881HalyardFBCH130-04_0005FBCH130-042026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532966HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532973HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532980HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160532997HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533000HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533017HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533024HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533031HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533048HalyardAVID MEDICAL, INC.LRO2026-09-05
10809160533055HalyardAVID MEDICAL, INC.LRO2026-09-05
10198956333420CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956395947CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956462977CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956486058CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956530744CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956531611CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956535985CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541177CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956541702CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956542532CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546509CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956546585CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956547285CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956548022CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956551763CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552364CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956552401CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956553385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04
10198956554429CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-04