AccessGUDID - DEVICE: LeMaitre Embolectomy Catheter (00840663100828)

GUDID

Device Identifier (DI) Information

Brand Name: LeMaitre Embolectomy Catheter
Version or Model: e1651-64
Commercial Distribution Status: In Commercial Distribution
Catalog Number: e1651-64
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663100828
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: 6F 40CM Over-the-Wire Embolectomy Catheter, eIFU

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):	Yes
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?
58174	Thrombectomy balloon catheter	A flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through distension of a balloon intended to dilate the stenosis. It is a balloon catheter that may include valves for the injection of contrast media/thrombolytic agents and/or an embolectomy coil for mechanical removal of the obstruction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022145	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: 301f1383-da3c-48c8-8314-f94a9fad8e6d
Public Version Date: October 24, 2022
Public Version Number: 5
DI Record Publish Date: July 15, 2015