Catalog Number

19310/0148

Brand Name

OCTAX Laser Shot

Version/Model Number

19310/0148

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2017

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

-

Product Code

MRX

Product Code Name

System, Assisted Reproduction Laser

Public Device Record Key

c4e210ae-5721-40c0-bbe0-990d675a2063

Public Version Date

May 03, 2019

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-