Catalog Number

2280.991

Brand Name

RIWOLITH

Version/Model Number

2280991

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FFK

Product Code Name

Lithotriptor, electro-hydraulic

Public Device Record Key

b90a1da7-c73f-4fd1-9fa5-978bca33456c

Public Version Date

September 19, 2018

Public Version Number

4

DI Record Publish Date

July 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-