ZQuiet S.A. - ZQuiet S.A. Dental Size D Single Unit - SLEEPING WELL, LLC

Duns Number:020904101

Device Description: ZQuiet S.A. Dental Size D Single Unit

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More Product Details

Catalog Number

-

Brand Name

ZQuiet S.A.

Version/Model Number

ZQSA-XDD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Device Record Status

Public Device Record Key

702f684b-ffc4-436c-9f0f-e466a26094b9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10858522003262

Quantity per Package

12

Contains DI Package

00858522003265

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SLEEPING WELL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5