FDA.reportPublic FDA data

Halyard

Primary DI
10809160468654
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
WRNM035-20_0001
Catalog number
WRNM035-20
Published
2025-05-30
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
10809160468654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080916046865410809160468654

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.

Sterilization Methods#

Method table
Method

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
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