Cardica PAS-Port Proximal Anastomosis System FG-000001

GUDID 11814900000017

PAS-Port Proximal Anastomosis System

AESDEX, LLC

Vascular-grafting anastomosis system

• Primary Device ID: 11814900000017
• NIH Device Record Key: a2885cb9-3060-4173-b553-3df422c0bd46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardica PAS-Port Proximal Anastomosis System
• Version Model Number: FG-000001
• Catalog Number: FG-000001
• Company DUNS: 081132841
• Company Name: AESDEX, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	11814900000017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091017

FDA Product Code

• FZP: Clip, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-19
• Device Publish Date: 2016-08-08

Devices Manufactured by AESDEX, LLC

• 11814900003100 - MicroCutter 30 White Reload: 2019-05-07 MicroCutter 30 White Reload is compatible with the MicroCutter 5/80 Stapler
• 11814900003117 - MicroCutter 30 Curved Tip White Reload: 2019-05-07 MicroCutter 30 Curved Tip White Reload is compatible with the MicroCutter 5/80 Stapler
• 11814900003209 - MicroCutter 30 Blue Reload: 2019-05-07 MicroCutter 30 Blue Reload is compatible with the MicroCutter 5/80 Stapler
• 11814900003216 - MicroCutter 30 Curved Tip Blue Reload: 2019-05-07 MicroCutter 30 Curved Tip Blue Reload is compatible with the MicroCutter 5/80 Stapler
• 11814900000031 - Cardica Vein/Aorta Gauge: 2019-03-11 The Vein/Aorta Gauge is a product that will assess outside diameter and wall thickness of a graft conduit and the outside diamet
• 11814900000017 - Cardica PAS-Port Proximal Anastomosis System: 2018-12-19PAS-Port Proximal Anastomosis System
• 11814900000017 - Cardica PAS-Port Proximal Anastomosis System: 2018-12-19 PAS-Port Proximal Anastomosis System
• 11814900001007 - Cardica C-Port xA Plus Anastomosis System: 2018-12-19 C-Port xA Plus Anastomosis System
• 11814900001502 - Cardica C-Port Flex-A Plus Distal Anastomosis Syst: 2018-12-19 C-Port FLEX-A Plus Distal Anastomosis System