Catalog Number

-

Brand Name

EMA

Version/Model Number

EMAGLDW

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

K971794

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

9d12340d-c729-46e5-99b8-3c4784fb8d8e

Public Version Date

September 20, 2021

Public Version Number

1

DI Record Publish Date

September 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-