HyperGlideTM

GUDID 00847536004863

104-4112 HYPERGLIDE 4X15MM BALLOON SYS

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 ID00847536004863
NIH Device Record Key3dba0c88-b245-49e4-8a0a-fcfc472025e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyperGlideTM
Version Model Number104-4112
Company DUNS826110710
Company NameMicro Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536004863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJNCatheter, intravascular occluding, temporary

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

[00847536004863]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-21
Device Publish Date2016-07-16

On-Brand Devices [HyperGlideTM]

00847536005730104-4530 HYPERGLIDE 5X30MM BALLOON SYS
00847536005709104-4530 HYPERGLIDE 5X30MM BALLOON SYS
00847536005679104-4520 HYPERGLIDE 5X20MM BALLOON SYS
00847536005648104-4520 HYPERGLIDE 5X20MM BALLOON SYS
00847536005617104-4515 HYPERGLIDE 5X15MM BALLOON SYS
00847536005587104-4515 HYPERGLIDE 5X15MM BALLOON SYS
00847536005297104-4315 HYPERGLIDE 3X15MM BALLOON SYS
00847536005266104-4315 HYPERGLIDE 3X15MM BALLOON SYS
00847536005235104-4310 HYPERGLIDE 3X10MM BALLOON SYS
00847536005204104-4310 HYPERGLIDE 3X10MM BALLOON SYS
00847536005105104-4132 HYPERGLIDE 4X30MM BALLOON SYS
00847536005075104-4132 HYPERGLIDE 4X30MM BALLOON SYS
00847536005020104-4127 HYPERGLIDE 4X20MM BALLOON SYS
00847536004986104-4127 HYPERGLIDE 4X20MM BALLOON SYS
00847536004948104-4113 HYPERGLIDE 4X10MM BALLOON SYS
00847536004863104-4112 HYPERGLIDE 4X15MM BALLOON SYS
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