HyperGlide 104-4315

GUDID 00836462004559

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: 00836462004559
• NIH Device Record Key: 25317c9e-fc7c-497e-af81-a296764fba34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperGlide
• Version Model Number: 104-4315
• Catalog Number: 104-4315
• 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

• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 Millimeter
• Outer Diameter: 3 Millimeter
• Length: 15 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	00836462004559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092495

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: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-10-06

On-Brand Devices [HyperGlide]

• 00836462004580: Occlusion Balloon System
• 00836462004559: Occlusion Balloon System
• 00836462004542: Occlusion Balloon System
• 00836462004481: Occlusion Balloon System
• 00836462004467: Occlusion Balloon System
• 00836462004177: Occlusion Balloon System
• 00836462004146: Occlusion Balloon System
• 00836462004122: Occlusion Balloon System
• 00836462004115: Occlusion Balloon System
• 00763000294595: BALLOON SYSTEM 104-4530 V20 HYPERGLIDE
• 00763000294564: BALLOON SYSTEM 104-4520 V20 HYPERGLIDE
• 00763000294533: BALLOON SYSTEM 104-4515 V20 HYPERGLIDE
• 00763000294502: BALLOON SYSTEM 104-4315 V20 HYPERGLIDE
• 00763000294472: BALLOON SYSTEM 104-4310 V20 HYPERGLIDE
• 00763000294441: BALLOON SYSTEM 104-4132 V20 HYPERGLIDE
• 00763000294410: BALLOON SYSTEM 104-4127 V20 HYPERGLIDE
• 00763000294380: BALLOON SYSTEM 104-4113 V20 HYPERGLIDE
• 00763000294359: BALLOON SYSTEM 104-4112 V20 HYPERGLIDE