Catalog Number

-

Brand Name

Valtrac

Version/Model Number

8886808800

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 2022

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

K931056

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

08ce136c-b602-41a1-9f31-0de5074b0be2

Public Version Date

January 11, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-