NavienTM

GUDID 00847536017986

RFX072-130-08 DCS CATHETERS FG

Micro Therapeutics, Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

Primary Device ID	00847536017986
NIH Device Record Key	1269dd56-030e-47a6-8a7b-22a1fc880bdd
Commercial Distribution Status	In Commercial Distribution
Brand Name	NavienTM
Version Model Number	RFX072-130-08
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	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
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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847536017986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K110055

FDA Product Code

DQY	CATHETER, PERCUTANEOUS

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

[00847536017986]

Ethylene Oxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-01-23
Device Publish Date	2016-04-07

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