Catalog Number

94108

Brand Name

POWERWAND™ XL

Version/Model Number

Maximum Barrier Kit 4Fr x 10cm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code

OWL

Product Code Name

Peripheral Catheter Insertion Kit

Public Device Record Key

d8e26430-f6b0-4d08-b422-fdefb0b0cffd

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Package DI Number

10859821006800

Quantity per Package

10

Contains DI Package

00859821006803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton