Catalog Number

-

Brand Name

Pillar

Version/Model Number

PDS3000M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2020

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

Yes

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

K110623,K110623

Product Code

LRK

Product Code Name

Device, Anti-Snoring

Public Device Record Key

2a9ffb63-0cdb-4770-8ae4-be7ce121c869

Public Version Date

March 18, 2021

Public Version Number

4

DI Record Publish Date

August 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-