FDA.reportPublic FDA data

Halyard

Primary DI
10809160531792
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SJGH114-13_0004
Catalog number
SJGH114-13
Published
2026-08-26
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
20809160531799PackageGS12In Commercial Distribution
10809160531792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053179920809160531799
1080916053179210809160531792

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
10809160539507HalyardAVMD020-01_0011AVMD020-012026-10-01
10809160539514HalyardDONS102-02_0001DONS102-022026-10-01
10809160539521HalyardRDLD003-15_0002RDLD003-152026-10-01
10809160539538HalyardSAMT109-11_0003SAMT109-112026-10-01
10809160539545HalyardSHAN430-07_0007SHAN430-072026-10-01
10809160539552HalyardMSMC114-07_0011MSMC114-072026-10-01
10809160539569HalyardDUPR37-02_0002DUPR37-022026-10-01
10809160539385HalyardGBTK48-02_0002GBTK48-022026-09-30
10809160539392HALYARDGBCC47-02GBCC47-022026-09-30
10809160539408HalyardDUEC64-04_0003DUEC64-042026-09-30
10809160539415HalyardHVBM218-03_0003HVBM218-032026-09-30
10809160539422HalyardSOLC12A-01_0001SOLC12A-012026-09-30
10809160539439HalyardHVSP200-05_0003HVSP200-052026-09-30
10809160539446HalyardHVSP212-04_0006HVSP212-042026-09-30
10809160539453HalyardGUGE09-02_0001GUGE09-022026-09-30
10809160539460HalyardMSMC121-03_0001MSMC121-032026-09-30
10809160539477HalyardSTJO002-08_0004STJO002-082026-09-30
10809160539484HalyardMSBM042-08_0006MSBM042-082026-09-30
10809160539491HalyardJACK400-06_0005JACK400-062026-09-30
10809160539217HalyardMMBN007-02_0016MMBN007-022026-09-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956379510CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956435643CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956507920CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956515635CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956541511CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956541528CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956592315CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956594760CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956595422CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956596245CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-30
10198956554344CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956559714CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956560178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956576964CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956582521CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956582811CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956585959CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590144CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590373CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590540CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956590694CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956591837CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956592193CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956592650CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956592667CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956594821CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10198956595439CARDINAL HEALTHCardinal Health 200, LLCOJG2026-09-29
10809160539224HalyardAVID MEDICAL, INC.OJG2026-09-29
10809160539286HALYARDAVID MEDICAL, INC.OJG2026-09-29
B098AMS14766C0Aligned Medical SolutionsAligned Medical SolutionsOJG2026-09-26