Catalog Number

SFTAC10

Brand Name

FasTouch™ Absorbable

Version/Model Number

SFTAC10

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

K181668,K181668

Product Code

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

9a2415ac-eeaa-4be0-9c6d-e3dd32078d98

Public Version Date

September 23, 2019

Public Version Number

1

DI Record Publish Date

September 14, 2019

Package DI Number

17290017155286

Quantity per Package

10

Contains DI Package

07290017155289

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-