AccessGUDID - DEVICE: WOLF Thrombectomy System, 7F (00850029546238)

GUDID

Device Identifier (DI) Information

Brand Name: WOLF Thrombectomy System, 7F
Version or Model: FD0427-04
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Devoro Medical Inc.

Primary DI Number: 00850029546238
Issuing Agency: GS1
Commercial Distribution End Date: February 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 117672411 *Terms of Use

Device Description: WOLF Thrombectomy System, 7F - 25cm x 140cm

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):	No
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?
61779	Thrombectomy wire-net	A device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEW	Peripheral Mechanical Thrombectomy With Aspiration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Length: 25 Centimeter

Device Record Status

Public Device Record Key: 10ae4b8d-986d-40b5-b8e1-17eb779ff070
Public Version Date: February 13, 2024
Public Version Number: 4
DI Record Publish Date: October 12, 2022