Catalog Number

-

Brand Name

ZQuiet S.A.

Version/Model Number

ZQSA-XDA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K140777,K140777

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

3507bcd9-c68d-49f2-bfc0-9df20098c51b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10858522003231

Quantity per Package

12

Contains DI Package

00858522003234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE