Catalog Number

-

Brand Name

Sunoptic Technologies

Version/Model Number

Fiberoptic Cables

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K901035

Product Code

FST

Product Code Name

Light, Surgical, Fiberoptic

Public Device Record Key

ec8f4006-db2a-4cc3-847c-88c317fd9732

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-