F-14 Flex

GUDID 14582233916295

Guidewire

FMD CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14582233916295
NIH Device Record Key768423f0-71d8-437f-925c-92ad4f005f08
Commercial Distribution StatusIn Commercial Distribution
Brand NameF-14 Flex
Version Model NumberF14F03ST235
Company DUNS696947837
Company NameFMD CO., LTD.
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

Device Dimensions

Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch
Length235 Centimeter
Outer Diameter0.014 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS104582233916298 [Primary]
GS114582233916295 [Package]
Contains: 04582233916298
Package: [5 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-28
Device Publish Date2024-08-20

On-Brand Devices [F-14 Flex]

14582233916301Guidewire
14582233916295Guidewire
14582233916288Guidewire

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