Catalog Number

S_717_1600

Brand Name

ACTEON

Version/Model Number

MINI USB2 DOCK

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

-

Product Code

NYH

Product Code Name

Plaque Disclosing Kit

Public Device Record Key

fa2cd39b-2923-41bb-9b41-c3841d6f0434

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

March 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-