Catalog Number

-

Brand Name

SYSTEM TWO LED

Version/Model Number

SD3-CNE

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100388,K100388

Product Code

FST

Product Code Name

Light, Surgical, Fiberoptic

Public Device Record Key

c1d73a81-28ff-4ea8-8319-fbcaed1de96c

Public Version Date

September 19, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

01816835021313

Quantity per Package

1

Contains DI Package

00816835021314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX