Catalog Number

-

Brand Name

Prosomnus IA Monogram

Version/Model Number

IA Monogram

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

K133683

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

bcfcde1c-8ef5-45a3-9ea1-f62f947718c1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-