FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160196830
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
RMRI095-04_0003
Catalog number
RMRI095-04
Published
2018-06-11
Public version status
Update
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160196837PackageGS14In Commercial Distribution
10809160196830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916019683720809160196837
1080916019683010809160196830

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, medicatedA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform an ENT surgical procedure. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153AVIDComplaints@Owens-Minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527191HalyardLIFE0091-12_0001LIFE0091-122026-07-16
10809160527207HalyardLIFE0242-02_0003LIFE0242-022026-07-16
10809160527214HalyardBMHT400-02_0008BMHT400-022026-07-16
10809160527221HalyardBMHT400-02_0009BMHT400-022026-07-16
10809160527238HalyardSGBS30-02SGBS30-022026-07-16
10809160527245HalyardDGCC52-03_0001DGCC52-032026-07-16
10809160527252HalyardLANC062-06_0001LANC062-062026-07-16
10809160527269HalyardVATX033-02_0001VATX033-022026-07-16
10809160527276HalyardMAMC222-16_0001MAMC222-162026-07-16
10809160527283HalyardPVHM214-02PVHM214-022026-07-16
10809160527290HalyardPVHM211-01PVHM211-012026-07-16
10809160527306HalyardLIFE0157-05_0001LIFE0157-052026-07-16
10809160527047HalyardLMLP08-01_0002LMLP08-012026-07-14
10809160527061HalyardKDAU216-02_0011KDAU216-022026-07-14
10809160527085HalyardDULP19_0005DULP192026-07-14
10809160527092HalyardAKCY76-01_0005AKCY76-012026-07-14
10809160527009HalyardBMHT101-05_0001BMHT101-052026-07-13
10809160527016HalyardBMHT103-05_0001BMHT103-052026-07-13
10809160527023HalyardBMHT102-03_0001BMHT102-032026-07-13
10809160526989HalyardLIFE0223-02_0005LIFE0223-022026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956444386CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956462175CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956472105CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477360CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956477391CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956479845CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956483439CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956488304CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956502437CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956504868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956507982CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956508149CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956509689CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956510548CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956510661CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956513679CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956518223CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956520707CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956522787CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956525412CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956525818CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956526457CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956526525CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527188CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527317CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527652CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16
10198956527768CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-16