GLIDEWIRE ADVANTAGE RA*FA14301C

GUDID 04987350745149

RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire

TERUMO CORPORATION

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID04987350745149
NIH Device Record Keyed585b35-05c6-47ac-95c8-e5d14912516e
Commercial Distribution StatusIn Commercial Distribution
Brand NameGLIDEWIRE ADVANTAGE
Version Model NumberGA1430
Catalog NumberRA*FA14301C
Company DUNS690543319
Company NameTERUMO 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
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

Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter
Outer Diameter0.36 Millimeter
Device Size Text, specify0
Length300 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. Keep away from rain. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS104987350745149 [Primary]
GS154987350745144 [Package]
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

DQXWire, guide, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-08
Device Publish Date2024-02-29

On-Brand Devices [GLIDEWIRE ADVANTAGE]

54987350717929RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
54987350716786RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
54987350714768RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
54987350714744RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
54987350703649RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
54987350703625RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
04987350745149RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
04987350745125RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
04987350745101RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire
04987350745088RADIFOCUS GLIDEWIRE ADVANTAGE Guidewire

Trademark Results [GLIDEWIRE ADVANTAGE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLIDEWIRE ADVANTAGE
GLIDEWIRE ADVANTAGE
77081115 3463168 Live/Registered
Terumo Kabushiki Kaisha
2007-01-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.