AtriClip® LAA Exclusion System A000968

GUDID 00818354015065

AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 50

ATRICURE, INC.

Ligation clip, metallic

• Primary Device ID: 00818354015065
• NIH Device Record Key: 7f203d9e-5014-4231-a4f6-0211dc2194a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AtriClip® LAA Exclusion System
• Version Model Number: PRO250
• Catalog Number: A000968
• Company DUNS: 006133784
• Company Name: ATRICURE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

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

Device Dimensions

• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius
• Handling Environment Temperature: Between 20 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354015065 [Primary]

FDA Product Code

• FZP: Clip, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-15
• Device Publish Date: 2016-04-08

On-Brand Devices [AtriClip® LAA Exclusion System]

• 00818354015065: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 50
• 00818354015058: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45
• 00818354015041: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 40
• 00818354015034: AtriClip® PRO2 Gilinov-Cosgrove LAA Exclusion System 35
• 00818354010497: Selection Guide, AOD1
• 30840143900253: Selection Guide, AOD1
• 30840143900208: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 50
• 30840143900192: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45
• 30840143900185: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 40
• 30840143900178: AtriClip® PRO2 Gilinov-Cosgrove LAA Exclusion System 35
• 30840143907474: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 50
• 30840143907412: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 45
• 30840143907351: AtriClip® PRO2 Gillinov-Cosgrove LAA Exclusion System 40
• 30840143907290: AtriClip® PRO2 Gilinov-Cosgrove LAA Exclusion System 35