AccessGUDID - DEVICE: Cardica PAS-Port Proximal Anastomosis System (11814900000017)

GUDID

Device Identifier (DI) Information

Brand Name: Cardica PAS-Port Proximal Anastomosis System
Version or Model: FG-000001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-000001
Company Name: AESDEX, LLC

Primary DI Number: 11814900000017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081132841 *Terms of Use

Device Description: PAS-Port Proximal Anastomosis System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44493	Vascular-grafting anastomosis system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZP	Clip, Implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091017	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2885cb9-3060-4173-b553-3df422c0bd46
Public Version Date: December 19, 2018
Public Version Number: 5
DI Record Publish Date: August 08, 2016