FDA.reportPublic FDA data

Halyard

Primary DI
10809160522417
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
SGSP11-03_0003
Catalog number
SGSP11-03
Published
2026-06-02
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
20809160522414PackageGS14In Commercial Distribution
10809160522417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916052241420809160522414
1080916052241710809160522417

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
true
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
10809160522332HalyardEURO055_0005EURO0552026-06-02
10809160522349HalyardUSAR052-17_0004USAR052-172026-06-02
10809160522356HalyardWILF002-23_0003WILF002-232026-06-02
10809160522363HalyardSGRB86-04_0009SGRB86-042026-06-02
10809160522370HalyardWINN109-05_0015WINN109-052026-06-02
10809160522387HalyardONEL028-03_0007ONEL028-032026-06-02
10809160522394HalyardNAMC414-09_0004NAMC414-092026-06-02
10809160522400HalyardKAFB005-21_0005KAFB005-212026-06-02
10809160522424HalyardMEHY02O_0009MEHY02O2026-06-02
10809160522431HalyardBMHT033-02_0010BMHT033-022026-06-02
10809160522448HalyardDGLP47-02_0008DGLP47-022026-06-02
10809160522165HalyardEURO011-09_0003EURO011-092026-06-01
10809160522172HalyardWILF024-22_0001WILF024-222026-06-01
10809160522189HalyardWILF011-24_0001WILF011-242026-06-01
10809160522196HalyardSGRB86-04_0006SGRB86-042026-06-01
10809160522202HalyardWILF004-22_0001WILF004-222026-06-01
10809160522219HalyardWILF027-21_0001WILF027-212026-06-01
10809160522233HalyardAVMD023-03_0001AVMD023-032026-06-01
10809160522240HalyardWILF002-23_0001WILF002-232026-06-01
10809160522257HalyardEURO018-08_0006EURO018-082026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956352711CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956362611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956384422CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956400238CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956450530CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956454897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956473218CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956475571CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956480629CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489288CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489325CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956491168CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956493056CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10809160521908HalyardAVID MEDICAL, INC.OJG2026-05-27
10193489375657NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10193489376845NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10080196471096NAMICMEDLINE INDUSTRIES, INC.OJG2026-04-24
10193489214383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489218220Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489417609Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489419641Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489422245Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489422719Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489423198Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489426984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489427943Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489444148Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08
10193489444605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJG2023-06-08