HyperForm 104-4415

GUDID 00836462004641

Occlusion Balloon System

Micro Therapeutics, Inc.

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00836462004641
• NIH Device Record Key: c4b379fa-0f4d-4c43-bd8b-801e58ac7053
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperForm
• Version Model Number: 104-4415
• Catalog Number: 104-4415
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 4 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836462004641 [Primary]

FDA Product Code

• MJN: Catheter, intravascular occluding, temporary

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: 2019-03-21
• Device Publish Date: 2015-10-06

On-Brand Devices [HyperForm]

• 00836462004689: Occlusion Balloon System
• 00836462004665: Occlusion Balloon System
• 00836462004641: Occlusion Balloon System
• 00836462004627: Occlusion Balloon System
• 00836462004603: Occlusion Balloon System
• 00836462004207: Occlusion Balloon System
• 00836462004184: Occlusion Balloon System
• 00763000294328: BALLOON SYSTEM 104-4770 V20 HYPERFORM
• 00763000294298: BALLOON SYSTEM 104-4715 V20 HYPERFORM
• 00763000294267: BALLOON SYSTEM 104-4470 V20 HYPERFORM
• 00763000294236: BALLOON SYSTEM 104-4420 V20 HYPERFORM
• 00763000294205: BALLOON SYSTEM 104-4415 V20 HYPERFORM
• 00763000294175: BALLOON SYSTEM 104-4370 V20 HYPERFORM
• 00763000294144: BALLOON SYSTEM 104-4153 V20 HYPERFORM