POWERWAND™ XL - The POWERWAND XL Introducer with Extended Dwell - ACCESS SCIENTIFIC, LLC

Duns Number:079290879

Device Description: The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE tr The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque

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More Product Details

Catalog Number

94119

Brand Name

POWERWAND™ XL

Version/Model Number

5Fr X 10cm Bifurcated

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

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

K131300,K131300,K131300

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

09600fcc-f475-4cc3-a8c9-593135e3fbf6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 31, 2017

Additional Identifiers

Package DI Number

30859821006538

Quantity per Package

12

Contains DI Package

20859821006531

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Overpack

"ACCESS SCIENTIFIC, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 59