Voss Coronary Bypass Sterile Marker

GUDID 00811304020041

Coronary Bypass Graft Marker (sterile)

VM CARDIO VASCULAR, INC.

Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker Polymeric coronary bypass marker 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)