Catalog Number

T1415-8SR

Brand Name

Surgimesh WN

Version/Model Number

T1415-8SR

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

23fd120a-daf8-4f48-8229-b3beac32c2c0

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

October 24, 2016

Package DI Number

3700296903944

Quantity per Package

5

Contains DI Package

03700296903968

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardbox