Catalog Number

D38239

Brand Name

Lightpaint on Surface

Version/Model Number

D38239

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2021

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

K162408

Product Code

EBD

Product Code Name

Coating, Filling Material, Resin

Public Device Record Key

39f80373-9226-4c81-96aa-c9299752ac95

Public Version Date

August 11, 2022

Public Version Number

4

DI Record Publish Date

April 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-