AccessGUDID - DEVICE: VenaCore Thrombectomy Catheter (00850291007406)

GUDID

Device Identifier (DI) Information

Brand Name: VenaCore Thrombectomy Catheter
Version or Model: AS-01160
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 46-101
Company Name: Inari Medical, Inc.

Primary DI Number: 00850291007406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 076827459 *Terms of Use

Device Description: VenaCore Thrombectomy Catheter

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?
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
KRA	Catheter, Continuous Flush

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K234034	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: 892546ab-00b5-4dba-b46a-2747a19f89ef
Public Version Date: February 09, 2026
Public Version Number: 2
DI Record Publish Date: March 27, 2024