Scanlan® RADIOMARK® graft markers 1001-831B

GUDID 00846159025644

Disk-shaped style, silicone, bulk NS, 10 per pk

SCANLAN INTERNATIONAL INC

Polymeric coronary bypass marker

• Primary Device ID: 00846159025644
• NIH Device Record Key: 227e9fed-d500-4f8f-9691-1fbb239500e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanlan® RADIOMARK® graft markers
• Version Model Number: 1001-831B
• Catalog Number: 1001-831B
• 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
• 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	00846159025644 [Primary]
GS1	00846159029444 [Unit of Use]

FDA Product Code

• MAB: Marker, Cardiopulmonary Bypass (Vein Marker)

Sterilization

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

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

[00846159025644]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• 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)