HyperGlideTM

GUDID 00847536005297

104-4315 HYPERGLIDE 3X15MM BALLOON SYS

Micro Therapeutics, Inc.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00847536005297
• NIH Device Record Key: 7319d01c-99b1-4d2e-b266-d8cb5c4a7e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperGlideTM
• Version Model 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536005297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101570

FDA Product Code

• MJN: Catheter, intravascular occluding, temporary

Sterilization

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

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

[00847536005297]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-08-04

On-Brand Devices [HyperGlideTM]

• 00847536005730: 104-4530 HYPERGLIDE 5X30MM BALLOON SYS
• 00847536005709: 104-4530 HYPERGLIDE 5X30MM BALLOON SYS
• 00847536005679: 104-4520 HYPERGLIDE 5X20MM BALLOON SYS
• 00847536005648: 104-4520 HYPERGLIDE 5X20MM BALLOON SYS
• 00847536005617: 104-4515 HYPERGLIDE 5X15MM BALLOON SYS
• 00847536005587: 104-4515 HYPERGLIDE 5X15MM BALLOON SYS
• 00847536005297: 104-4315 HYPERGLIDE 3X15MM BALLOON SYS
• 00847536005266: 104-4315 HYPERGLIDE 3X15MM BALLOON SYS
• 00847536005235: 104-4310 HYPERGLIDE 3X10MM BALLOON SYS
• 00847536005204: 104-4310 HYPERGLIDE 3X10MM BALLOON SYS
• 00847536005105: 104-4132 HYPERGLIDE 4X30MM BALLOON SYS
• 00847536005075: 104-4132 HYPERGLIDE 4X30MM BALLOON SYS
• 00847536005020: 104-4127 HYPERGLIDE 4X20MM BALLOON SYS
• 00847536004986: 104-4127 HYPERGLIDE 4X20MM BALLOON SYS
• 00847536004948: 104-4113 HYPERGLIDE 4X10MM BALLOON SYS
• 00847536004863: 104-4112 HYPERGLIDE 4X15MM BALLOON SYS