SilverSpeed 103-0602-175

GUDID 00836462003057

14 Hydrophilic Guidewire

Micro Therapeutics, Inc.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00836462003057
NIH Device Record Keybf919474-052f-4c3a-b4a9-7f3b0ebcc0e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilverSpeed
Version Model Number103-0602-175
Catalog Number103-0602-175
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid extreme temperatures;Keep dry;AVOID DIRECT SUNLIGHT

Device Identifiers

Device Issuing AgencyDevice ID
GS100836462003057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-06

On-Brand Devices [SilverSpeed]

0083646200311816 Hydrophilic Guidewire
0083646200306414 Hydrophilic Guidewire
0083646200305714 Hydrophilic Guidewire
0083646200301910 Hydrophilic Guidewire

Trademark Results [SilverSpeed]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SILVERSPEED
SILVERSPEED
76331813 2685752 Dead/Cancelled
KONINKLIJKE PHILIPS ELECTRONICS N.V.
2001-10-30
SILVERSPEED
SILVERSPEED
75586104 2278214 Live/Registered
COVIDIEN LP
1998-11-10
SILVERSPEED
SILVERSPEED
74087318 1675624 Dead/Cancelled
CHEMCO EUROPE N.V.
1990-08-13

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