Guidewire 0.018 4/220cm angled (Straub Medical®) - The Rotarex™ S and Aspirex™ S Guidewire has a - Straub Medical AG

Duns Number:488489766

Device Description: The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with

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More Product Details

Catalog Number

80233

Brand Name

Guidewire 0.018 4/220cm angled (Straub Medical®)

Version/Model Number

Version 1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

3275f656-31a0-4e38-a7f3-f5ac02cf3e46

Public Version Date

July 01, 2022

Public Version Number

6

DI Record Publish Date

January 31, 2020

Additional Identifiers

Package DI Number

07640142811169

Quantity per Package

5

Contains DI Package

07640142810247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

REF80320 Carton box

"STRAUB MEDICAL AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 34