Catalog Number

M0068407500

Brand Name

LithoClast

Version/Model Number

DT-488

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

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

57ec6c98-0bc3-48c5-a8aa-f4239d238484

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 03, 2017

Package DI Number

07613353121013

Quantity per Package

5

Contains DI Package

07613353120511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton