Catalog Number

-

Brand Name

CHATTANOOGA

Version/Model Number

Intelect F-SW

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2017

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P080028

Product Code

NBN

Product Code Name

Generator, Shock-Wave, For Pain Relief

Public Device Record Key

61e77d69-ff50-4571-af7e-0c5b232f2489

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-