Catalog Number

TECG3004

Brand Name

ProSup

Version/Model Number

TECG3004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 12, 2016

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

K982532

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

7581ae25-fbf8-4adb-adfb-ea9be47d5332

Public Version Date

October 29, 2019

Public Version Number

5

DI Record Publish Date

October 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-