MultiTASC Dissection/Transection Device

Basic Information

• Brand Name: MultiTASC Dissection/Transection Device
• Primary DI: 00840663105892
• Version / Model: 4500-10
• Catalog Number: 4500-10
• Company Name: Lemaitre Vascular, Inc.
• Labeler DUNS: 184805166
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-15
• Public Version: 4
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: 12750f33-d38b-440a-801c-ac0f641513ab

Device Description

MultiTASC Dissection/Transection Device, 12mm

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
31729	Intraluminal artery stripper, reusable	A 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 the "MollRing cutter". Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840663105892	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K121415	000