Catalog Number

-

Brand Name

Lacrimal Plug

Version/Model Number

ESK-1003

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

7c7bca42-94f0-4afc-b6a7-fd8212271973

Public Version Date

April 12, 2019

Public Version Number

2

DI Record Publish Date

October 01, 2018

Package DI Number

10812444028765

Quantity per Package

10

Contains DI Package

00812444028768

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-