VenaCure

GUDID H787165100010

Venacure EVLT NeverTouch Direct Introducer Sheath

ANGIODYNAMICS, INC.

Varicose vein lasing procedure kit

• Primary Device ID: H787165100010
• NIH Device Record Key: 243f68cd-a11a-41b4-9b95-0eea40720ae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VenaCure
• Version Model Number: 16510001
• Company DUNS: 079105071
• Company Name: ANGIODYNAMICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Catheter Gauge: 4 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684014724 [Secondary]
HIBCC	H787165100010 [Primary]
HIBCC	H787165100011 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170695

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-25
• Device Publish Date: 2017-07-24

On-Brand Devices [VenaCure]

• H787165100010: Venacure EVLT NeverTouch Direct Introducer Sheath
• 15051684015134: VenaCure 1470 Laser