FDA.reportPublic FDA data

HALYARD

Primary DI
10809160538562
Brand
HALYARD
Company
AVID MEDICAL, INC.
Model
IHCR36-02
Catalog number
IHCR36-02
Published
2026-09-21
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
20809160538569PackageGS12In Commercial Distribution
10809160538562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916053856920809160538569
1080916053856210809160538562

GMDN Terms#

Term, Definition table
TermDefinition
Craniotomy kitA collection of various sterile basic instruments, dressings and the necessary materials used to perform a craniotomy procedure. It typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160540787HalyardBPVP85-01_0002BPVP85-012026-10-19
10809160540794HalyardTNCA09_0007TNCA092026-10-19
10809160540800HalyardJCLC12F_0009JCLC12F2026-10-19
10809160540817HalyardMWOS97-02MWOS97-022026-10-19
10809160540824HalyardUSAR034-20_0013USAR034-202026-10-19
10809160540831HalyardEURO055-01_0007EURO055-012026-10-19
10809160540664HalyardDUDV85-02_0001DUDV85-022026-10-16
10809160540671HalyardDAGV13-03_0001DAGV13-032026-10-16
10809160540688HalyardDGAG83-05_0001DGAG83-052026-10-16
10809160540695HalyardDAGL72-02_0001DAGL72-022026-10-16
10809160540701HALYARDBPHD16-02BPHD16-022026-10-16
10809160540718HALYARDBPKB46-02BPKB46-022026-10-16
10809160540725HALYARDBPSF60-02BPSF60-022026-10-16
10809160540732HalyardSPSA58-02SPSA58-022026-10-16
10809160540756HALYARDBPCY61-02BPCY61-022026-10-16
10809160540763HALYARDBPTH37-02BPTH37-022026-10-16
10809160540657HalyardSELF154_0011SELF1542026-10-15
10809160540565HalyardMSBM032-06_0002MSBM032-062026-10-13
10809160540572HalyardSOLC12A-01_0003SOLC12A-012026-10-13
10809160540589HalyardEAMC102-10_0003EAMC102-102026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956038127CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956268111CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956537439CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956562660CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956565586CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956592209CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956598027CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956599321CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956604087CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956604230CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956606777CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956608115CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956608405CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956608665CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956610224CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956612297CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956613133CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10198956613737CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-19
10809160540725HALYARDAVID MEDICAL, INC.OJG2026-10-16
10198956543577CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956572287CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956592230CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-15
10198956603240CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956604025CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-13
10198956493803CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956542174CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956556423CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956561304CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956568105CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12
10198956571211CARDINAL HEALTHCardinal Health 200, LLCOJG2026-10-12