Isolator Surgical Ablation System A000248

GUDID 30840143901595

Glidepath Tape (GPT100) (1-Unit)

ATRICURE, INC.

Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer Cardiac ablation system applicator introducer/sizer

• Primary Device ID: 30840143901595
• NIH Device Record Key: 8759bad2-f272-42f6-92cd-2e62ea44677c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolator Surgical Ablation System
• Version Model Number: GPT100
• Catalog Number: A000248
• 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 [Previous]
GS1	10840143900006 [Primary]
GS1	30840143901595 [Package]; Contains: 10840143900006; Package: box [1 Units]; In Commercial Distribution
GS1	50840143903036 [Package]; Package: case [18 Units]; In Commercial Distribution

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: 2021-01-18
• Device Publish Date: 2021-01-08

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• 30840143901595: Glidepath Tape (GPT100) (1-Unit)