Catalog Number

-

Brand Name

Swiss DolorClast

Version/Model Number

EL-341

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"

-

For Single-Use

-

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

P050004

Product Code

NBN

Product Code Name

Generator, Shock-Wave, For Pain Relief

Public Device Record Key

43d748b6-596d-4ee9-a315-6747b7161a4a

Public Version Date

September 24, 2018

Public Version Number

5

DI Record Publish Date

October 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-