Lariat

GUDID 00818354017557

Suture Delivery Device

ATRICURE, INC.

Suture knot pusher, single-use

• Primary Device ID: 00818354017557
• NIH Device Record Key: dcae217b-dbfe-4896-bc79-5afd15a95bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lariat
• Version Model Number: RS
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354017557 [Primary]
HIBCC	M95530060 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153096

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: 2020-01-07
• Device Publish Date: 2019-12-30

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