FDA.reportPublic FDA data

Halyard

Primary DI
10809160527771
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SFSBPCR13-02_0002
Catalog number
SFSBPCR13-02
Published
2026-07-23
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

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
10809160527771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916052777110809160527771

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.

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527757HalyardKOOT802-03_0001KOOT802-032026-07-23
10809160527764HalyardBPCR13-02_0004BPCR13-022026-07-23
10809160527788HalyardSFSBPPU55-02_0002SFSBPPU55-022026-07-23
10809160527795HalyardBPCR13-02_0001BPCR13-022026-07-23
10809160527801HalyardBPRC87-02_0003BPRC87-022026-07-23
10809160527818HalyardSFSBPRC87-02_0003SFSBPRC87-022026-07-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527764HalyardAVID MEDICAL, INC.OJG2026-07-23
10809160527795HalyardAVID MEDICAL, INC.OJG2026-07-23
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