Periscope Dissector

Basic Information

• Brand Name: Periscope Dissector
• Primary DI: 00840663102563
• Version / Model: 4200-00
• Catalog Number: 4200-00
• Company Name: Lemaitre Vascular, Inc.
• Labeler DUNS: 184805166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-06-30
• Public Version: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 014872a6-4b13-4789-a882-ab47ff99913d

Device Description

Periscope Dissector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWX	Stripper, Artery, Intraluminal	Cardiovascular	870.4875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840663102563	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K003719	000