SION blue PLUS

GUDID 14547327139943

ASAHI INTECC CO., LTD.

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID14547327139943
NIH Device Record Key79ad71fd-4a48-498c-8ecd-a75a99fdcbba
Commercial Distribution StatusIn Commercial Distribution
Brand NameSION blue PLUS
Version Model NumberAHW14R327P
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

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
GS104547327139946 [Primary]
GS114547327139943 [Package]
Contains: 04547327139946
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-15
Device Publish Date2025-05-07

On-Brand Devices [SION blue PLUS]

14547327139943AHW14R327P
14547327139936AHW14R327J
14547327139929AHW14R327S
14547327139882AHW14R027P
14547327139875AHW14R027J
14547327139868AHW14R027S

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