FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160048481
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
SLHS085_0003
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160048488PackageGS14In Commercial Distribution
10809160048481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916004848820809160048488
1080916004848110809160048481

GMDN Terms#

Term, Definition table
TermDefinition
Vascular-grafting anastomosis systemAn assembly of sterile devices designed to create an opening between a blood vessel and a vascular graft (native or synthetic) during a vascular surgical procedure [e.g., coronary artery bypass grafting (CABG), or arteriovenous fistula (AVF) grafting]. It typically includes a delivery tool loaded with metallic clips/connectors/couplers (e.g., surgical stainless steel). A blood vessel graft is loaded into the delivery tool, and upon manual actuation of the tool, the fastening devices are deployed through the graft and into the target vessel, and the tool creates an opening in the target vessel (e.g., aortotomy, arteriotomy). This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10809160526156HALYARDPVHM204-02PVHM204-022026-07-06
10809160526484HalyardLANC009-34_0008LANC009-342026-07-06
10809160526491HalyardSGMN13-04_0011SGMN13-042026-07-06
10809160526507HalyardAVMD054_0002AVMD0542026-07-06
10809160526514HalyardSHAN446-04_0002SHAN446-042026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450486436Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
00884450488812Merit Medical®Merit Medical Systems, Inc.OEZ2026-07-09
10198956119437CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
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10198956360358CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956365056CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956418424CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956421479CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956439870CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956462182CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956480834CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956483408CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956485662CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956488861CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956490871CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956491502CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492080CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956492332CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956496415CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956502420CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503113CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956503915CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504011CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956504325CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956507104CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956511057CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956512603CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956514331CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956517639CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09
10198956518391CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-09