FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160202005
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
NAFB066-01_0004
Catalog number
NAFB066-01
Published
2018-07-25
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160202002PackageGS12In Commercial Distribution
10809160202005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916020200220809160202002
1080916020200510809160202005

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. 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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10198956448483CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
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10198956507685CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508019CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956508170CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509382CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956509603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16
10198956510418CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-16