Cardica Vein/Aorta Gauge FG-000003

GUDID 11814900000031

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

AESDEX, LLC

Open-surgery vascular sizer, reusable
Primary Device ID11814900000031
NIH Device Record Key29465ad3-be1c-42e1-8827-fb83b204d02c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardica Vein/Aorta Gauge
Version Model NumberFG-000003
Catalog NumberFG-000003
Company DUNS081132841
Company NameAESDEX, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS111814900000031 [Primary]

FDA Product Code

DWSInstruments, Surgical, Cardiovascular

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


[11814900000031]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-19

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11814900003209 - MicroCutter 30 Blue Reload2019-05-07 MicroCutter 30 Blue Reload is compatible with the MicroCutter 5/80 Stapler
11814900003216 - MicroCutter 30 Curved Tip Blue Reload2019-05-07 MicroCutter 30 Curved Tip Blue Reload is compatible with the MicroCutter 5/80 Stapler
11814900000031 - Cardica Vein/Aorta Gauge2019-03-11The 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
11814900000031 - Cardica Vein/Aorta Gauge2019-03-11 The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diamet
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