F-14 Tapered 30

GUDID 14582233916202

Guidewire

FMD CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14582233916202
NIH Device Record Keyf0beeb6a-d2b8-4707-979f-41154df3f023
Commercial Distribution StatusIn Commercial Distribution
Brand NameF-14 Tapered 30
Version Model NumberF14T30ST300
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

Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch
Length300 Centimeter
Outer Diameter0.014 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS104582233916205 [Primary]
GS114582233916202 [Package]
Contains: 04582233916205
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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-08-19
Device Publish Date2022-12-26

On-Brand Devices [F-14 Tapered 30]

14582233916202Guidewire
14582233916196Guidewire

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