Catalog Number

EPTFE-SHEET-011

Brand Name

ePTFE Sheet

Version/Model Number

Size: 8cm x 3cm x 1mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K071470

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

aaf2314f-f1bd-4625-8d74-9e6ff78acec9

Public Version Date

November 14, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-