Catalog Number

4X3-M

Brand Name

StarTrol

Version/Model Number

4X3-M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

Issuing Agency

In HIBCC

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

-

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

FSS

Product Code Name

Light, surgical, floor standing

Public Device Record Key

acb4a65f-5e64-4aad-ab2f-9c4816b73f0f

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

January 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-