Catalog Number

8886808300

Brand Name

Valtrac

Version/Model Number

8886808300

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 03, 2020

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

ce642014-c825-4c83-a465-0d49d1a8cebd

Public Version Date

September 15, 2020

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

-