FDA.reportPublic FDA data

Halyard

Primary DI
10809160404638
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SJGH114-07_0002
Catalog number
SJGH114-07
Published
2023-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
20809160404635PackageGS12In Commercial Distribution
10809160404638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916040463520809160404635
1080916040463810809160404638

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.

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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527191HalyardLIFE0091-12_0001LIFE0091-122026-07-16
10809160527207HalyardLIFE0242-02_0003LIFE0242-022026-07-16
10809160527214HalyardBMHT400-02_0008BMHT400-022026-07-16
10809160527221HalyardBMHT400-02_0009BMHT400-022026-07-16
10809160527238HalyardSGBS30-02SGBS30-022026-07-16
10809160527245HalyardDGCC52-03_0001DGCC52-032026-07-16
10809160527252HalyardLANC062-06_0001LANC062-062026-07-16
10809160527269HalyardVATX033-02_0001VATX033-022026-07-16
10809160527276HalyardMAMC222-16_0001MAMC222-162026-07-16
10809160527283HalyardPVHM214-02PVHM214-022026-07-16
10809160527290HalyardPVHM211-01PVHM211-012026-07-16
10809160527306HalyardLIFE0157-05_0001LIFE0157-052026-07-16
10809160527047HalyardLMLP08-01_0002LMLP08-012026-07-14
10809160527061HalyardKDAU216-02_0011KDAU216-022026-07-14
10809160527085HalyardDULP19_0005DULP192026-07-14
10809160527092HalyardAKCY76-01_0005AKCY76-012026-07-14
10809160527009HalyardBMHT101-05_0001BMHT101-052026-07-13
10809160527016HalyardBMHT103-05_0001BMHT103-052026-07-13
10809160527023HalyardBMHT102-03_0001BMHT102-032026-07-13
10809160526989HalyardLIFE0223-02_0005LIFE0223-022026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956260016CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956469617CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956494022CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956497788CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956500228CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956502253CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956514812CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956514843CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956520486CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956527683CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956528215CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956528253CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956529298CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10198956530614CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-16
10197106896327CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956489165CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956491625CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956492141CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956502581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956518384CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956526501CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956527553CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528185CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528437CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10198956528727CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-09
10809160526897HalyardAVID MEDICAL, INC.OJG2026-07-08
10198956416079CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956502062CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06
10198956515536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-06