Catalog Number

6-47-501

Brand Name

Saturn 5 Laser System

Version/Model Number

Saturn 5 Laser System Fixed with RI Viewer Software

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

K141434

Product Code

MRX

Product Code Name

System, assisted reproduction laser

Public Device Record Key

59ab8564-ee61-4e11-8338-c3b1060a3356

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 22, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-