Catalog Number

-

Brand Name

SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long

Version/Model Number

6403, 6403-A

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)

Yes

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

4bbe6b8e-565b-44ec-9bcc-968ebda330c3

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Package DI Number

30845819000237

Quantity per Package

10

Contains DI Package

10845819000233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton