FDA.report

AVID TruCustom

Primary DI
20809160044831
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
ADVR024-05_0005
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OGDCustom anesthesia tray

Product Code Classifications

CodeDeviceSpecialtyClass
OGDCustom Anesthesia TrayAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160044831PackageGS120In Commercial Distribution
10809160044834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916004483120809160044831
1080916004483410809160044834

GMDN Terms

TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10809160521816HalyardDUOH90-03_0001DUOH90-032026-05-26
10809160521823HalyardDUOH90-03_0004DUOH90-032026-05-26
10809160521830HalyardVAMH014-07_0007VAMH014-072026-05-26
10809160521847HalyardARMC007-02_0007ARMC007-022026-05-26
10809160521731HalyardWINN122-09_0004WINN122-092026-05-22
10809160521762HalyardUSAR061-08_0004USAR061-082026-05-22
10809160521779HalyardWINN112-06_0014WINN112-062026-05-22
10809160521786HalyardUIPP85-02UIPP85-022026-05-22
10809160521793HalyardWINN112-06_0002WINN112-062026-05-22
10809160521809HalyardESFS76-01_0007ESFS76-012026-05-22
20809160517236HalyardDRRD48-02_0004DRRD48-022026-03-24
20809160517243HalyardAVMD050-01_0007AVMD050-012026-03-24
20809160517250HalyardUSAR017-12_0006USAR017-122026-03-24
20809160517090HalyardLIFE0240_0006LIFE02402026-03-23
20809160517120HalyardKAFB027_0010KAFB0272026-03-23
20809160517137HalyardUFCF010-03_0008UFCF010-032026-03-23
20809160517144HalyardVMCD018-11_0004VMCD018-112026-03-23
20809160517151HalyardVAML019-09_0004VAML019-092026-03-23
20809160517168HalyardNHJV7000-20_0008NHJV7000-202026-03-23
20809160517175HalyardEAMC109-06_0008EAMC109-062026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20809160463489HalyardAVID MEDICAL, INC.OGD2026-03-02
20809160463960HalyardAVID MEDICAL, INC.OGD2026-03-02
20809160464073HalyardAVID MEDICAL, INC.OGD2026-03-02
20809160506674HalyardAVID MEDICAL, INC.OGD2025-12-17
20809160506117HalyardAVID MEDICAL, INC.OGD2025-12-12
20809160493561HalyardAVID MEDICAL, INC.OGD2025-09-04
20809160493578HalyardAVID MEDICAL, INC.OGD2025-09-04
20809160492748HalyardAVID MEDICAL, INC.OGD2025-08-22
20809160487706HalyardAVID MEDICAL, INC.OGD2025-07-31
20809160488307HalyardAVID MEDICAL, INC.OGD2025-07-31
20809160471200HalyardAVID MEDICAL, INC.OGD2025-06-25
20809160470319HalyardAVID MEDICAL, INC.OGD2025-06-16
20809160468804HalyardAVID MEDICAL, INC.OGD2025-05-31
20809160467500HalyardAVID MEDICAL, INC.OGD2025-05-19
20809160467517HalyardAVID MEDICAL, INC.OGD2025-05-19
20809160467531HalyardAVID MEDICAL, INC.OGD2025-05-19
20809160463267HalyardAVID MEDICAL, INC.OGD2025-04-11
20809160463274HalyardAVID MEDICAL, INC.OGD2025-04-11
20809160463281HalyardAVID MEDICAL, INC.OGD2025-04-11
20809160462277HalyardAVID MEDICAL, INC.OGD2025-04-02
20809160462284HalyardAVID MEDICAL, INC.OGD2025-04-02
20809160461812HalyardAVID MEDICAL, INC.OGD2025-03-27
20809160458218HalyardAVID MEDICAL, INC.OGD2025-02-22
20809160457310HalyardAVID MEDICAL, INC.OGD2025-02-18
20809160457327HalyardAVID MEDICAL, INC.OGD2025-02-18
20809160457150HalyardAVID MEDICAL, INC.OGD2025-02-13
20809160456009HalyardAVID MEDICAL, INC.OGD2025-02-10
20809160455606HalyardAVID MEDICAL, INC.OGD2025-02-05
20809160455521HalyardAVID MEDICAL, INC.OGD2025-02-04
20809160455125HalyardAVID MEDICAL, INC.OGD2025-01-30