AccessGUDID - DEVICE: Wirion Delivery Catheter (72900155120202)

GUDID

Device Identifier (DI) Information

Brand Name: Wirion Delivery Catheter
Version or Model: P2-9-0701
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: P2-9-0701
Company Name: GARDIA MEDICAL LTD

Primary DI Number: 72900155120202
Issuing Agency: GS1
Commercial Distribution End Date: July 16, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 531908965 *Terms of Use

Device Description: The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Delivery Catheter: Contains and delivers a Filter Unit, locks it onto the guide wire using the Activating Handle and deploys it in the target vessel (Fig. 1). The Filter Unit is made of a filter membrane and a Nitinol frame. A 5cc syringe with a soft needle is supplied for flushing the system prior to use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
44841	Embolic protection filtering guidewire	A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NTE	Temporary Carotid Catheter For Embolic Capture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143570	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: 715d1263-f201-443d-9338-57e4e116b12a
Public Version Date: April 09, 2019
Public Version Number: 5
DI Record Publish Date: August 11, 2016