ClearView MV Atrial Depressor

GUDID 00818354013955

ClearView MV Atrial Depressor

ATRICURE, INC.

Cardiac retractor

• Primary Device ID: 00818354013955
• NIH Device Record Key: 5f986dab-fbd7-4f11-a066-5647a2cbf72b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearView MV Atrial Depressor
• Version Model Number: 001-400-005
• 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: true
• 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

Customer Support Contacts

• Phone: 866-349-2342
• Email: xxx@xxx.xxx
• Phone: 866-349-2342
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354013955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053021

FDA Product Code

• DTS: Sucker, Cardiotomy Return, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-24

On-Brand Devices [ClearView MV Atrial Depressor]

• 00818354013962: ClearView MV Atrial Depressor with Quick Connect
• 00818354013955: ClearView MV Atrial Depressor