SofTIP FG-0008

GUDID 30840143901809

SofTIP Guide Cannula

ATRICURE, INC.

Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use Suture cutter, single-use

• Primary Device ID: 30840143901809
• NIH Device Record Key: c154e4bc-2669-415b-81d0-a4cd6d01eb03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SofTIP
• Version Model Number: 60-02
• Catalog Number: FG-0008
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com
• Phone: 650-354-1200
• Email: info@sentreheart.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354017601 [Previous]
GS1	10840143901812 [Primary]
GS1	30840143901809 [Package]; Contains: 10840143901812; Package: box [1 Units]; In Commercial Distribution
GS1	50840143901780 [Package]; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090385

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2021-01-19
• Device Publish Date: 2021-01-11

On-Brand Devices [SofTIP]

• 00818354017601: A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligat
• 30840143901809: SofTIP Guide Cannula
• 30840143903698: SofTIP Guide Cannula
• 30840143909645: SofTIP Guide Cannula