FDA.reportPublic FDA data

Cardica Vein/Aorta Gauge

Primary DI
11814900000031
Brand
Cardica Vein/Aorta Gauge
Company
AESDEX, LLC
Model
FG-000003
Catalog number
FG-000003
Device description
The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diameter of a target vessel for reference only.
Published
2019-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
11814900000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1181490000003111814900000031

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery vascular sizer, reusableAn invasive instrument intended to be used during open vascular surgery to approximate the size of a blood vessel for selection of an appropriately sized vascular device/implant (e.g., vascular graft, emboli filter); it is not intended to obtain a precise measurement. The device typically consists of a C-shaped (half circle) sizing portion with a handle, sometimes available in a range of sizes, and is intended to size the outer diameter of the blood vessel (i.e., extraluminal sizing); it may in addition be used to size a vascular graft. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081132841
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
11814900003100MicroCutter 30 White ReloadFG-025310FG-0253102016-08-08
11814900003117MicroCutter 30 Curved Tip White ReloadFG-025311FG-0253112016-08-08
11814900003209MicroCutter 30 Blue ReloadFG-025320FG-0253202016-08-08
11814900003216MicroCutter 30 Curved Tip Blue ReloadFG-025321FG-0253212016-08-08
11814900000017Cardica PAS-Port Proximal Anastomosis SystemFG-000001FG-0000012016-08-08
11814900001007Cardica C-Port xA Plus Anastomosis SystemFG-000100FG-0001002016-08-08
11814900001502Cardica C-Port Flex-A Plus Distal Anastomosis SystemFG-000150FG-0001502016-08-08
11814900003025Dextera MicroCutter 5/80 StaplerFG-025302FG-0253022016-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219527688DELACROIX-CHEVALIERLANDANGERDWS2026-09-27
00724995286651V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286668V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286675V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286682V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
10884389855416NAMICMEDLINE INDUSTRIES, INC.DWS2026-09-25
04058749012446NAFehling Instruments GmbH & Co. KGDWS2026-09-21
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
B040PHR10Premature Hinged Sternal RetractorGENESEE BIOMEDICAL, INC.DWS2026-09-18
00190776429119MillenniumAvalign Technologies, Inc.DWS2026-09-04
00884450456217Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456224Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
00884450456231Merit Medical®Merit Medical Systems, Inc.DWS2026-09-04
04058749008944NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749012521NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749036350NAFehling Instruments GmbH & Co. KGDWS2026-09-04
04058749122626NAFehling Instruments GmbH & Co. KGDWS2026-09-04
00190776423933MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776423971MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424114MillenniumAvalign Technologies, Inc.DWS2026-08-27
00190776424138MillenniumAvalign Technologies, Inc.DWS2026-08-27
00884450450970Merit Medical®Merit Medical Systems, Inc.DWS2026-08-27
00190776419707MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420284MillenniumAvalign Technologies, Inc.DWS2026-08-25
00190776420390MillenniumAvalign Technologies, Inc.DWS2026-08-25
04058749004496NAFehling Instruments GmbH & Co. KGDWS2026-08-25
00190776417130MillenniumAvalign Technologies, Inc.DWS2026-08-19
00190776416973MillenniumAvalign Technologies, Inc.DWS2026-08-18
00190776417000MillenniumAvalign Technologies, Inc.DWS2026-08-18
00198506094064ELMED INCORPORATEDELMED INCORPORATEDDWS2026-08-18