NavienTM

GUDID 00847536017849

RFX058-125-08 DCS CATHETERS FG

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use
Primary Device ID00847536017849
NIH Device Record Key5ffc555d-1369-485e-9c43-740ee43fa36b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavienTM
Version Model NumberRFX058-125-08
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 Kitfalse
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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry, dark place

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536017849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


[00847536017849]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2016-04-07

On-Brand Devices [NavienTM]

00847536018044RFX072-95-08MP DCS CATHETERS FG
00847536018020RFX072-95-08 DCS CATHETERS FG
00847536018006RFX072-130-08MP DCS CATHETERS FG
00847536017986RFX072-130-08 DCS CATHETERS FG
00847536017962RFX072-125-08MP DCS CATHETERS FG
00847536017948RFX072-125-08 DCS CATHETERS FG
00847536017924RFX072-115-08MP DCS CATHETERS FG
00847536017900RFX072-115-08 DCS CATHETERS FG
00847536017894RFX058-130-08 DCS CATHETERS FG
00847536017887RFX072-105-08MP DCS CATHETERS FG
00847536017863RFX072-105-08 DCS CATHETERS FG
00847536017849RFX058-125-08 DCS CATHETERS FG
00847536017795RFX058-115-08 DCS CATHETERS FG
00847536017740RFX058-105-08 DCS CATHETERS FG

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