Catalog Number

M0068407320

Brand Name

Rigid Pneumatic Probe

Version/Model Number

M0068407320

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

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

FFK

Product Code Name

Lithotriptor, electro-hydraulic

Public Device Record Key

f1fa54a0-92dd-4503-aeb4-7fd4c8c3f583

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

March 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-