Catalog Number

TEALFIL-8

Brand Name

SURGIMESH®EASYPLUG®

Version/Model Number

TEALFIL-8

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

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

8b98edd0-00ab-48d8-99c6-6eb877334e76

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

October 23, 2015

Package DI Number

03700296903838

Quantity per Package

5

Contains DI Package

03700296900844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box