VenaSeal™

Basic Information

• Brand Name: VenaSeal™
• Primary DI: 00643169986268
• Version / Model: VS-402
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-25
• Public Version: 4
• Public Version Date: 2022-04-20
• Public Version Status: Update
• Public Device Record Key: 5d1f27fd-83f6-4b5b-84ef-daabb4e18d53
• Distribution End Date: 2018-12-07

Device Description

VS-402 VENASEAL CLOSURE SYSTEM X5

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJQ	Agent, occluding, vascular, permanent	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58708	Varicose vein adhesive-treatment kit	A collection of sterile devices intended to be used for the endovascular closure of the great saphenous vein (GSV) and associated varicosities as a treatment for varicose veins. It typically includes a surgical adhesive (e.g., cyanoacrylate), syringe, delivery catheter, dilator, introducer and a dispensing gun. The adhesive is typically delivered under ultrasonic control at prescribed intervals throughout the length of the affected vein to adhere the vessel walls together, resulting in the complete and permanent closure of the lumen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20643169986262	GS1	PK	5	Not in Commercial Distribution	2018-12-07
Primary	00643169986268	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P140018	006

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry