Voss Coronary Bypass Sterile Marker

GUDID 00811304020041

Coronary Bypass Graft Marker (sterile)

VM CARDIO VASCULAR, INC.

Polymeric coronary bypass marker

• Primary Device ID: 00811304020041
• NIH Device Record Key: 29bb4029-9240-446c-9ed1-32697c90e866
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Voss Coronary Bypass Sterile Marker
• Version Model Number: 40149
• Company DUNS: 799240457
• Company Name: VM CARDIO VASCULAR, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811304020041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895369

FDA Product Code

• KPK: Marker, Ostia, Aorto-Saphenous Vein

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: 2016-01-05

Devices Manufactured by VM CARDIO VASCULAR, INC.

• 00811304020065 - Voss Coronary Bypass Vein Flushing Cannula: 2019-02-21 Vein flushing Cannula for Coronary Bypass (sterile)
• 00811304020096 - Voss Coronary Bypass Vein Flushing Cannula: 2019-02-21 Coronary Bypass Vein Flushing Cannula (non-sterile)
• 00811304020041 - Voss Coronary Bypass Sterile Marker: 2018-07-06Coronary Bypass Graft Marker (sterile)
• 00811304020041 - Voss Coronary Bypass Sterile Marker: 2018-07-06 Coronary Bypass Graft Marker (sterile)
• 00811304020058 - Voss Coronary Bypass Vein Clamp: 2018-07-06 Coronary Bypass Vein Clamp
• 00811304020072 - Voss Non-Sterile Coronary Bypass Graft Marker: 2018-07-06 Coronary Bypass Graft Marker-Non-sterile
• 00811304020089 - Voss Coronary Bypass Vein Clamp: 2018-07-06 Coronary Bypass Vein Clamp (non-sterile)