Catalog Number

L1US01US

Brand Name

Lunoa

Version/Model Number

L1US01US

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

K180608,K180608

Product Code

MYB

Product Code Name

Pillow, cervical (for mild sleep apnea)

Public Device Record Key

6d401458-8f52-4cea-8a45-255c8c4c073a

Public Version Date

September 20, 2018

Public Version Number

1

DI Record Publish Date

August 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-