Duns Number:020904101
Device Description: Contains 3 of each of the following packaged assemblies:ZQuiet S.A. Dental Size A Single U Contains 3 of each of the following packaged assemblies:ZQuiet S.A. Dental Size A Single Unit - DI: 00858522003234ZQuiet S.A. Dental Size B Single Unit - DI: 00858522003241ZQuiet S.A. Dental Size C Single Unit - DI: 00858522003258ZQuiet S.A. Dental Size D Single Unit - DI: 00858522003265
Catalog Number
-
Brand Name
ZQuiet S.A.
Version/Model Number
ZQSA-XD12M
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
Product Code
LRK
Product Code Name
Device, Anti-Snoring
Public Device Record Key
195dd513-0ac0-49ed-987b-86c4cdba2aad
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |