R350 7390

GUDID 20841156111448

R350 Guidewire

TELEFLEX INCORPORATED

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID20841156111448
NIH Device Record Keyfdb70efd-8fec-4a77-b714-81667f9b3347
Commercial Distribution StatusIn Commercial Distribution
Brand NameR350
Version Model NumberIPN930522
Catalog Number7390
Company DUNS002348191
Company NameTELEFLEX INCORPORATED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM
Phone+1(919)544-8000
EmailCS@TELEFLEX.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS110841156111441 [Primary]
GS120841156111448 [Package]
Contains: 10841156111441
Package: Box [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 Date2025-06-12
Device Publish Date2025-06-04

On-Brand Devices [R350]

50841156101174R350 V2 Guidewire
20841156111448R350 Guidewire

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