ePTFE Sheet - ePTFE Sheet - IMPLANTECH ASSOCIATES, INC.

Duns Number:784664955

Device Description: ePTFE Sheet

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

EPTFE-SHEET-063

Brand Name

ePTFE Sheet

Version/Model Number

Size: 9cm x 6cm x 6mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

83941d63-a9e0-4056-a7f9-7391c490743e

Public Version Date

December 08, 2020

Public Version Number

1

DI Record Publish Date

November 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMPLANTECH ASSOCIATES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 1251