Catalog Number

-

Brand Name

Provox® ActiValve® Lubricant

Version/Model Number

7149

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092593

Product Code

EWL

Product Code Name

Prosthesis, Laryngeal (Taub)

Public Device Record Key

ccf50c84-3d0a-47a8-a1c2-b10e3654ed54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-