MarksmanTM

GUDID 00847536026254

FA-55135-1030 MARKSMAN 135CM

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 ID00847536026254
NIH Device Record Key3a68c2c5-faae-4f48-94b2-4581df5e1d17
Commercial Distribution StatusIn Commercial Distribution
Brand NameMarksmanTM
Version Model NumberFA-55135-1030
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

Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit
Storage Environment TemperatureBetween 129 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536026254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, continuous flush

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

[00847536026254]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-01-23
Device Publish Date2017-05-20

On-Brand Devices [MarksmanTM]

00847536026278FA-55160-1030 MARKSMAN 160CM
00847536026261FA-55150-1030 MARKSMAN 150CM
00847536026254FA-55135-1030 MARKSMAN 135CM
00847536026230FA-55105-1015 MARKSMAN 105CM
00847536008335FA-55160-1030 MARKSMAN CATHETER 160CM
00847536008328FA-55150-1030 MARKSMAN CATHETER 150CM
00847536008311FA-55135-1030 MARKSMAN CATHETER 135CM
00847536008304FA-55105-1015 MARKSMAN CATHETER 105CM
00847536003934FA-55160-1030 MARKSMAN 160 CM
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