FDA.reportPublic FDA data

Halyard

Primary DI
10809160469644
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SGSP91-02_0001
Catalog number
SGSP91-02
Published
2025-06-11
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
20809160469641PackageGS12In Commercial Distribution
10809160469644PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916046964120809160469641
1080916046964410809160469644

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
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527719HalyardKOOT801-03_0002KOOT801-032026-07-22
10809160527726HalyardLDSF0001_0004LDSF00012026-07-22
10809160527733HalyardLDSF0002_0002LDSF00022026-07-22
10809160527740HalyardLDSF0003_0002LDSF00032026-07-22
10809160527597HalyardBPTJ33-01_0006BPTJ33-012026-07-21
10809160527603HALYARDPVHM223-02PVHM223-022026-07-21
10809160527610HALYARDPVHM221-02PVHM221-022026-07-21
10809160527627HalyardHVBM208-02_0005HVBM208-022026-07-21
10809160527634HalyardBPMY56-02BPMY56-022026-07-21
10809160527641HalyardNHJV6000-22_0006NHJV6000-222026-07-21
10809160527658HalyardKOOT800-01_0003KOOT800-012026-07-21
10809160527672HalyardSHND401-05_0010SHND401-052026-07-21
10809160527689HalyardMEEP10-01_0008MEEP10-012026-07-21
10809160527696HalyardHVBM222-02_0003HVBM222-022026-07-21
10809160527702HalyardSGGR61-04_0002SGGR61-042026-07-21
10809160527542HalyardUSAR053-16_0001USAR053-162026-07-20
10809160527559HalyardSAMM034-21_0001SAMM034-212026-07-20
10809160527566HalyardWILF003-24_0004WILF003-242026-07-20
10809160527573HalyardAVMD057_0001AVMD0572026-07-20
10809160527580HalyardSAMM066-18_0001SAMM066-182026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527610HALYARDAVID MEDICAL, INC.OJG2026-07-21
10198956175303CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956395435CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956398900CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956402706CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956415256CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956483385CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956502574CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956506541CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956508002CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956508040CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956512467CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956512931CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956513198CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956513525CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956514928CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956515550CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956516236CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525290CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525436CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525696CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527577CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527775CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527812CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527881CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528024CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528871CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956529120CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956530515CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20