Solitaire FR SFR-4-15

GUDID 00836462016132

Revascularization Device

Micro Therapeutics, Inc.

Thrombectomy suction catheter
Primary Device ID00836462016132
NIH Device Record Keyf5cb66a0-edc8-42f9-9d3a-131bda844e3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolitaire FR
Version Model NumberSFR-4-15
Catalog NumberSFR-4-15
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
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0
Length26 Millimeter
Outer Diameter4 Millimeter
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100836462016132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCATHETER, THROMBUS RETRIEVER

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 Date2015-10-23

On-Brand Devices [Solitaire FR]

00836462016163Revascularization Device
00836462016156Revascularization Device
00836462016149Revascularization Device
00836462016132Revascularization Device

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