SOLOPATH SR-2235

GUDID 50389701012280

SOLOPATH Re-collapsible Access System

TERUMO MEDICAL CORPORATION

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable
Primary Device ID50389701012280
NIH Device Record Key0c07f7dd-0a24-49a8-9845-13464da90fd8
Commercial Distribution Discontinuation2019-11-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSOLOPATH
Version Model NumberSR-2235
Catalog NumberSR-2235
Company DUNS131489882
Company NameTERUMO MEDICAL CORPORATION
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(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com
Phone+1(800)283-7866
Emailtmccustomer.admin@terumomedical.com

Device Dimensions

Length35 Centimeter
Length35 Centimeter
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length35 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store at extreme temperature and humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100389701012285 [Primary]
GS150389701012280 [Package]
Contains: 00389701012285
Package: Carton [39 Units]
Discontinued: 2019-11-15
Not in Commercial Distribution

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-12
Device Publish Date2018-05-17

On-Brand Devices [SOLOPATH]

50389701012303SOLOPATH Re-collapsible Access System
50389701012297SOLOPATH Re-collapsible Access System
50389701012280SOLOPATH Re-collapsible Access System
50389701012273SOLOPATH Re-collapsible Access System
50389701012266SOLOPATH Re-collapsible Balloon Access System
50389701012259SOLOPATH Re-collapsible Balloon Access System
50389701012242SOLOPATH Re-collapsible Access System
50389701012235SOLOPATH Re-collapsible Access System
50389701012228SOLOPATH Balloon Expandable TransFemoral System
50389701012211SOLOPATH Balloon Expandable TransFemoral System
50389701012204SOLOPATH Balloon Expandable TransFemoral System
50389701012198SOLOPATH Balloon Expandable TransFemoral System
50389701012181SOLOPATH Balloon Expandable TransFemoral System
50389701012174SOLOPATH Balloon Expandable TransFemoral System
50389701012167SOLOPATH Balloon Expandable TransFemoral System
50389701012150SOLOPATH Balloon Expandable TransFemoral System
50389701012143SOLOPATH Balloon Expandable TransFemoral System
50389701012136SOLOPATH Balloon Expandable TransFemoral System

Trademark Results [SOLOPATH]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLOPATH
SOLOPATH
77137053 3565247 Live/Registered
Onset Medical Corporation
2007-03-21

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