FDA.reportPublic FDA data

Halyard

Primary DI
10809160530269
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SJGH104-07_0002
Catalog number
SJGH104-07
Published
2026-08-18
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
10809160530269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916053026910809160530269

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
10809160530696HalyardPVHM227-02_0003PVHM227-022026-08-19
10809160530702HalyardPVHM224-02_0005PVHM224-022026-08-19
10809160530719HalyardPVHM218-02_0002PVHM218-022026-08-19
10809160530726HalyardPVHM220-02_0002PVHM220-022026-08-19
10809160530733HalyardPVHM207-02_0001PVHM207-022026-08-19
10809160530740HalyardPVHM201-02_0004PVHM201-022026-08-19
10809160530757HalyardPVHM205-02_0003PVHM205-022026-08-19
10809160530764HalyardPVHM221-02_0001PVHM221-022026-08-19
10809160530771HalyardPVHM216-02_0003PVHM216-022026-08-19
10809160530788HalyardPVHM223-02_0005PVHM223-022026-08-19
10809160530795HalyardPVHM214-02_0002PVHM214-022026-08-19
10809160530801HalyardPVHM211-01_0002PVHM211-012026-08-19
10809160530818HalyardPVHM219-02_0002PVHM219-022026-08-19
10809160530825HalyardPVHM225-01_0004PVHM225-012026-08-19
10809160530832HalyardPVHM208-02_0005PVHM208-022026-08-19
10809160530894HalyardNCDS018-02_0010NCDS018-022026-08-19
10809160530900HalyardPVHM229-02_0006PVHM229-022026-08-19
10809160530252HalyardSHAN426-09_0003SHAN426-092026-08-18
10809160530276HalyardSHAN408-05_0003SHAN408-052026-08-18
10809160530283HalyardSHAN410-05_0003SHAN410-052026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160530696HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530757HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530764HalyardAVID MEDICAL, INC.OJG2026-08-19
10809160530832HalyardAVID MEDICAL, INC.OJG2026-08-19
10198956469990CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956554825CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956556300CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956556317CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10198956557697CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-18
10809160530559HalyardAVID MEDICAL, INC.OJG2026-08-18
10198956533899CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956535961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956544581CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956548756CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10198956553231CARDINAL HEALTHCardinal Health 200, LLCOJG2026-08-17
10809160528396HalyardAVID MEDICAL, INC.OJG2026-08-03
10809160528587HalyardAVID MEDICAL, INC.OJG2026-08-03
10198956327603CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956353961CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956504936CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956506947CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956513570CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956521346CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956524125CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956531130CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534131CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956534674CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956538672CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542297CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31
10198956542921CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-31