ONYX 18

GUDID 00847536006171

105-7100-060 ONYX 18 KIT AVM US

Micro Therapeutics, Inc.

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Primary Device ID00847536006171
NIH Device Record Key03a1c2a6-6ea6-4172-a573-009f5523e8e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameONYX 18
Version Model Number105-7100-060
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment TemperatureBetween 19 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536006171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MFEAgent, injectable, embolic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-23
Device Publish Date2015-04-17

On-Brand Devices [ONYX 18]

00847536006171105-7100-060 ONYX 18 KIT AVM US
00836462005044Liquid Embolic 105-7100-060 Onyx 18

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