AccessGUDID - DEVICE: EndoHelix Retrieval Device (00840663102587)

GUDID

Device Identifier (DI) Information

Brand Name: EndoHelix Retrieval Device
Version or Model: 4200-20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4200-20
Company Name: Lemaitre Vascular, Inc.

Primary DI Number: 00840663102587
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184805166 *Terms of Use

Device Description: EndoHelix Retrieval Device

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?
37335	Intraluminal artery stripper, single-use	A sterile, hand-held, manual surgical instrument designed to perform an endarterectomy (the removal of plaque deposits from arteriosclerotic arteries) during a vasculature reconstruction procedure. It is typically made of high-grade stainless steel and is available in various designs including an endohelic form (a tubular device with an expanding helical element at the distal tip which is controlled by the surgeon through a sliding mechanism on the handle). Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWX	Stripper, Artery, Intraluminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032105	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: 9afdd229-9fc4-46c6-a9f8-770db2f90952
Public Version Date: April 21, 2021
Public Version Number: 4
DI Record Publish Date: June 30, 2015