FIELDER XT-R

GUDID 14547327085097

ASAHI INTECC CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14547327085097
NIH Device Record Keyb34c29a0-628d-4801-916b-85331ae7cac9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIELDER XT-R
Version Model NumberAPW14R005S
Company DUNS690711189
Company NameASAHI INTECC 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

Outer Diameter0.014 Inch
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
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
GS104547327085090 [Primary]
GS114547327085097 [Package]
Contains: 04547327085090
Package: [5 Units]
In Commercial Distribution

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 Number5
Public Version Date2019-11-22
Device Publish Date2016-09-16

On-Brand Devices [FIELDER XT-R]

14547327085103APW14R305S
14547327085097APW14R005S

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