F-18 Hard 15

GUDID 14582233916240

Guidewire

FMD CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14582233916240
NIH Device Record Key36cac375-88b3-430b-8ff3-8df3bde6fb84
Commercial Distribution StatusIn Commercial Distribution
Brand NameF-18 Hard 15
Version Model NumberF18H15ST300
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 Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch
Length300 Centimeter
Outer Diameter0.018 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS104582233916243 [Primary]
GS114582233916240 [Package]
Contains: 04582233916243
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-18 Hard 15]

14582233916240Guidewire
14582233916233Guidewire

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.