FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160155486
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
AXBL001-01_0003
Catalog number
AXBL001-01
Published
2017-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
20809160155483PackageGS110In Commercial Distribution
10809160155486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916015548320809160155483
1080916015548610809160155486

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.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527009HalyardBMHT101-05_0001BMHT101-052026-07-13
10809160527016HalyardBMHT103-05_0001BMHT103-052026-07-13
10809160527023HalyardBMHT102-03_0001BMHT102-032026-07-13
10809160526989HalyardLIFE0223-02_0005LIFE0223-022026-07-10
10809160526996HalyardBMHT110-04_0001BMHT110-042026-07-10
10809160526903HalyardBTMF007-06_0001BTMF007-062026-07-09
10809160526910HalyardDGBB41-02_0004DGBB41-022026-07-09
10809160526927HalyardBMHT200-03_0004BMHT200-032026-07-09
10809160526934HalyardSGCB56-03_0006SGCB56-032026-07-09
10809160526941HalyardSFSSHND415-02_0001SFSSHND415-022026-07-09
10809160526958HalyardLAKC010-08_0004LAKC010-082026-07-09
10809160526965HalyardSFSAKAH37-04_0001SFSAKAH37-042026-07-09
10809160526842HalyardAKCS54-03_0001AKCS54-032026-07-08
10809160526859HalyardDUAG11-01_0007DUAG11-012026-07-08
10809160526880HalyardSELF108-04_0005SELF108-042026-07-08
10809160526897HalyardHVSP206-05_0007HVSP206-052026-07-08
10809160526804HalyardSBHP01-02_0008SBHP01-022026-07-07
10809160526811HalyardAVMD027-02_0002AVMD027-022026-07-07
10809160526828HalyardSGGR61-04_0003SGGR61-042026-07-07
10809160526835HalyardSGCY35-02_0007SGCY35-022026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS190580Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-12
10198956255586CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956334373CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956381773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956393059CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956393103CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956397620CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956400665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956401754CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956426344CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956442429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956450806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956462625CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956464810CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956468443CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956475908CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956477773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956479586CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956480155CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956484290CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956489363CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956489974CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956492097CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956493506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956494145CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956494381CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956497733CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956497801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956499096CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956499799CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09