Isolator Surgical Ablation System A000294

GUDID 00818354010435

Glidepath Tape (3-Unit)

ATRICURE, INC.

Cardiac ablation system applicator introducer/sizer

• Primary Device ID: 00818354010435
• NIH Device Record Key: 284346eb-4f09-4249-b632-032d97e56138
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolator Surgical Ablation System
• Version Model Number: GPT100
• Catalog Number: A000294
• Company DUNS: 006133784
• Company Name: ATRICURE, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354010435 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-13
• Device Publish Date: 2018-11-12

On-Brand Devices [Isolator Surgical Ablation System ]

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• 00818354011326: Glidepath Tape (3-Unit)
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• 00818354010893: Coolrail Linear Pen, 30 mm linear electrode
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• 00818354010756: Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve
• 00818354010473: Isolator Linear Pen, 20 mm linear electrode
• 00818354010435: Glidepath Tape (3-Unit)
• 00818354010343: Isolator Transpolar Pen
• 00818354016499: Coolrail Linear Pen, 30 mm linear electrode
• 30840143902103: Isolator Linear Pen, 20 mm linear electrode
• 30840143902523: Isolator Long Pen TT, 33 cm long pen
• 30840143902455: Coolrail Linear Pen, 30 mm linear electrode
• 30840143902387: Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve
• 30840143902257: Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve
• 30840143901984: Isolator Transpolar Pen
• 30840143900000: Isolator Synergy Access Surgical Ablation System
• 30840143901618: Glidepath Tape (GPT200) (3-Unit)
• 30840143901595: Glidepath Tape (GPT100) (1-Unit)