Catalog Number

SV1001

Brand Name

SilkVoice

Version/Model Number

SV1001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180631

Product Code

MIX

Product Code Name

System, Vocal Cord Medialization

Public Device Record Key

e49f2c83-f7a9-4aae-8635-9223d40dc0cd

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

March 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-