Axius Coronary Shunt OF-3000

GUDID 00607567700677

Axius Coronary Shunt

MAQUET CARDIOVASCULAR LLC

Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt

• Primary Device ID: 00607567700677
• NIH Device Record Key: 61518b75-3786-4259-8be7-20a18d1b355f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axius Coronary Shunt
• Version Model Number: OF-3000
• Catalog Number: OF-3000
• Company DUNS: 022348156
• Company Name: MAQUET CARDIOVASCULAR LLC
• 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: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com
• Phone: 888-880-2874
• Email: cssurgery@maquet.com

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607567700673 [Primary]
GS1	00607567700677 [Package]; Contains: 00607567700673; Package: 5 pack box [5 Units]; Discontinued: 2018-05-29; Not in Commercial Distribution
GS1	20607567700677 [Package]; Contains: 00607567700673; Package: 5 pack box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010117

FDA Product Code

• DXC: Clamp, Vascular

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: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Axius Coronary Shunt ]

• 00607567700707: Axius Coronary Shunt, Long Length
• 00607567700691: Axius Coronary Shunt, Long Length
• 00607567700684: Axius Coronary Shunt
• 00607567700677: Axius Coronary Shunt
• 00607567700660: Axius Coronary Shunt
• 00607567700653: Axius Coronary Shunt
• 00607567700646: Axius Coronary Shunt
• 00607567700639: Axius Coronary Shunt
• 00607567700622: Axius Coronary Shunt
• 00607567700615: Axius Coronary Shunt
• 00607567700608: Axius Coronary Shunt
• 00607567700592: Axius Coronary Shunt