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
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
00190776407438MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407513MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407315MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776407360MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776405830MillenniumAvalign Technologies, Inc.DWS2026-07-26
03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
00190776404222MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405748MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14