Catalog Number

-

Brand Name

Autolith 115V

Version/Model Number

9-201-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K923822,K923822

Product Code

FFK

Product Code Name

Lithotriptor, Electro-Hydraulic

Public Device Record Key

a38c9c40-5776-47f4-b64c-d8c25d94db0c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 14, 2016

Package DI Number

00817183020387

Quantity per Package

1

Contains DI Package

00817183020370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-