F-14 Tapered 3

GUDID 14582233916158

Guidewire

FMD CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14582233916158
NIH Device Record Keyac32b4dc-69e2-4602-b7d0-240be14bd7b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameF-14 Tapered 3
Version Model NumberF14T03ST190
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

Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch
Length190 Centimeter
Outer Diameter0.014 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS104582233916151 [Primary]
GS114582233916158 [Package]
Contains: 04582233916151
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 Tapered 3]

14582233916165Guidewire
14582233916158Guidewire

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