Scanlan® RADIOMARK® graft markers 1001-831

GUDID 10846159001041

Disk-shaped style, silicone (1 per sterile pkg)

SCANLAN INTERNATIONAL 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

• Primary Device ID: 10846159001041
• NIH Device Record Key: 08b10e0a-057b-4f4b-a3b0-2bf17e7f3cd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanlan® RADIOMARK® graft markers
• Version Model Number: 1001-831
• Catalog Number: 1001-831
• Company DUNS: 023055619
• Company Name: SCANLAN INTERNATIONAL INC
• Device Count: 10
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651 298-0997
• Email: vanderpoelw@scanlangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846159001044 [Unit of Use]
GS1	10846159001041 [Primary]

FDA Product Code

• MAB: Marker, Cardiopulmonary Bypass (Vein Marker)

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: 2021-02-05
• Device Publish Date: 2015-08-27

On-Brand Devices [Scanlan® RADIOMARK® graft markers]

• 00846159025644: Disk-shaped style, silicone, bulk NS, 10 per pk
• 10846159001041: Disk-shaped style, silicone (1 per sterile pkg)