Catalog Number

K1039062

Brand Name

Dornier MedTech

Version/Model Number

Delta III

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

K172084

Product Code

LNS

Product Code Name

Lithotriptor, Extracorporeal Shock-Wave,Urological

Public Device Record Key

534ab9dd-08a3-4cee-b7f8-28c9de8b97e2

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-