VenaCure EVLT

GUDID H787EVLT80OPS0

VenaCure 80cm Procedure Kit w/ Spotlight OPS Sheath

ANGIODYNAMICS, INC.

Varicose vein lasing procedure kit

• Primary Device ID: H787EVLT80OPS0
• NIH Device Record Key: 1f363070-2009-4d97-8f86-09d29fff9152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VenaCure EVLT
• Version Model Number: EVLT/80-OPS
• 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

• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787EVLT80OPS0 [Primary]
HIBCC	H787EVLT80OPS5 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041957

FDA Product Code

• GEX: Powered laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-01
• Device Publish Date: 2019-01-11

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• H787EVLT25OPS0: VenaCure 25cm Procedure Kit w/ Spotlight OPS Sheath, 1 Fiber w/ SMA Connector
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• H787514030090: NeverTouch FRS 45cm Procedure Kit
• H787514030080: NeverTouch FRS 25cm Procedure Kit
• H787514030070: NeverTouch FRS 65cm Procedure Kit
• H787514030050: NeverTouch FRS 65cm Procedure Kit
• H787514030020: NeverTouch FRS 65cm Procedure Kit
• H787514030010: NeverTouch FRS 45cm Procedure Kit
• H787114030130: NeverTouch FRS 65cm Procedure Kit
• H787114030120: NeverTouch FRS 45cm Procedure Kit
• H787114030070: NeverTouch FRS 90cm Procedure Kit
• H787114030060: NeverTouch FRS 65cm Procedure Kit
• H787114030050: NeverTouch FRS 45cm Procedure Kit
• H787114030040: NeverTouch FRS 90cm Procedure Kit
• H787114030030: NeverTouch FRS 25cm Procedure Kit
• H787114030020: NeverTouch FRS 65cm Procedure Kit
• H787114030010: NeverTouch FRS 45cm Procedure Kit
• H787EVLTPVAKUS0: VenaCure 400 Micron Perforator and Accessory Vein Ablation Kit
• H787514020080: NeverTouch 65cm Procedure Kit
• H787514020070: NeverTouch 45cm Procedure Kit
• H787514020060: NeverTouch 65cm Procedure Kit
• H787514020050: NeverTouch 45cm Procedure Kit
• H787114033025: VenaCure Tre-Sheath Set
• H787114031015: NeverTouch Direct Procedure Kit, 1 Fiber w/ SMA 905 Connector
• H787114020020: NeverTouch 65cm Procedure Kit
• H787114020010: NeverTouch 45cm Procedure Kit
• 15051684020848: VenaCure OPS 55cm EVLT Fiber