AccessGUDID - DEVICE: ProCatid System kit Finished Good (07290015512015)

GUDID

Device Identifier (DI) Information

Brand Name: ProCatid System kit Finished Good
Version or Model: P2-9-0705-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P2-9-0705-S
Company Name: GARDIA MEDICAL LTD

Primary DI Number: 07290015512015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531908965 *Terms of Use
Previous DI: 72900155120103

Device Description: The ProCatid Embolic Protection System is a temporary embolic protection system, filtering distal to the intervention site. It is provided sterile and for single use. The system is a rapid exchange, pre-loaded filter that can be used with commercially available 0.014" guide wires. After the guidewire of choice is properly located in the target vessel, the filter is delivered, locked and deployed on the wire, at any location according to physician's discretion. The locking mechanism is remotely activated, allowing the stand-alone filter unit to be positioned in any location along the vessel without compromising wire performance and support. At the end of the procedure, the filter is retrieved along with the wire. SYSTEM COMPONENTS: 1 Delivery Catheter DI 7290015512022 1 Retrieval Catheter DI 7290015512039

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:	Yes
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: 1539c72e-6586-4d99-a5db-76d3f0943b0a
Public Version Date: July 20, 2020
Public Version Number: 5
DI Record Publish Date: February 12, 2017