Catalog Number

ESP-1003

Brand Name

Stephens Instruments

Version/Model Number

ESP-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

K020882,K020882,K020882

Product Code

LZU

Product Code Name

Plug, punctum

Public Device Record Key

b91fa61f-7758-43c8-aeae-233ddd3f31a7

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 20, 2020

Package DI Number

00851807007217

Quantity per Package

10

Contains DI Package

00810061910930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box