Catalog Number

FTP25

Brand Name

FasTouch™

Version/Model Number

FTP25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

K162252,K162252

Product Code

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

385a1ff0-f1e3-423d-a9e2-038459ea90e2

Public Version Date

May 06, 2020

Public Version Number

6

DI Record Publish Date

August 21, 2017

Package DI Number

17290017155101

Quantity per Package

5

Contains DI Package

07290017155104

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box