Catalog Number

-

Brand Name

Pelion 6 Month Plug

Version/Model Number

PPD0204

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LZU

Product Code Name

Plug, Punctum

Public Device Record Key

4ac9afce-f67a-4c5a-83ac-16ebe9bb9bf5

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Package DI Number

10810020085362

Quantity per Package

10

Contains DI Package

00810020085365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-