ArcTM

GUDID 00847536003927

ARC-160 DYSON MINI CATHETER US

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00847536003927
• NIH Device Record Key: d7768546-e889-45a0-ad0a-0e050e5d936f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArcTM
• Version Model Number: ARC-160
• Company DUNS: 826110710
• Company Name: Micro Therapeutics, 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: false
• Expiration Date: false
• 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: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry, cool place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536003927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150107

FDA Product Code

• DQY: CATHETER, PERCUTANEOUS

Sterilization

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

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

[00847536003927]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-04-07

On-Brand Devices [ArcTM]

• 00847536024625: CATHETER ARC-160 MINI V02 US CANADA
• 00847536024618: CATHETER ARC-132 V02 US CANADA
• 00847536003927: ARC-160 DYSON MINI CATHETER US
• 00847536003460: ARC-132 DYSON CATHETER US