Catalog Number

-

Brand Name

Tacker

Version/Model Number

OMS-TTH

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 03, 2021

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

K090470,K090470

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

3ce962d8-9b47-4d55-9b41-52b57e619213

Public Version Date

September 14, 2022

Public Version Number

5

DI Record Publish Date

September 02, 2015

Package DI Number

20884521070452

Quantity per Package

5

Contains DI Package

10884521070455

Package Discontinue Date

November 03, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE