FDA.reportPublic FDA data

Halyard

Primary DI
20809160302924
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
VARV049-03_0003
Catalog number
VARV049-03
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160302924PackageGS12In Commercial Distribution
10809160302927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916030292420809160302924
1080916030292710809160302927

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.

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
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
10809160540565HalyardMSBM032-06_0002MSBM032-062026-10-13
10809160540572HalyardSOLC12A-01_0003SOLC12A-012026-10-13
10809160540589HalyardEAMC102-10_0003EAMC102-102026-10-13
10809160540596HalyardDUAD22-01_0008DUAD22-012026-10-13
10809160540602HalyardMAMC236-19_0003MAMC236-192026-10-13
10809160540497HALYARDBPKN15-02BPKN15-022026-10-12
10809160540510HALYARDBPCL47-02BPCL47-022026-10-12
10809160540527HALYARDBPEX22-02BPEX22-022026-10-12
10809160540534HALYARDBPLA73-02BPLA73-022026-10-12
10809160540541HALYARDBPSA20-02BPSA20-022026-10-12
10809160540558HALYARDGBPM39-02GBPM39-022026-10-12
10809160540428HalyardEURO017-10_0002EURO017-102026-10-09
10809160540435HalyardEAMC103-08_0005EAMC103-082026-10-09
10809160540442HalyardMAMC235-17_0001MAMC235-172026-10-09
10809160540459HalyardMAMC220-12_0002MAMC220-122026-10-09
10809160540466HalyardDNKN06_0012DNKN062026-10-09
10809160540091HalyardSGEP43-03_0005SGEP43-032026-10-08
10809160540114HalyardDNSP11_0008DNSP112026-10-08
10809160540121HalyardDNVP97_0006DNVP972026-10-08
10809160540138HalyardDNPP09_0011DNPP092026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956603240CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956604025CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956493803CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956542174CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956556423CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956561304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956568105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956571211CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956573277CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956578746CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956594289CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956598294CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600140CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600485CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956600553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601109CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601192CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601406CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956601741CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956602045CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10809160540190HalyardAVID MEDICAL, INC.OJG2026-10-08
10198956141018CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956314351CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956458925CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541559CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956541627CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956544918CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956550681CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956559790CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06
10198956561342CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-06