Catalog Number

JJ55H

Brand Name

Valutrus

Version/Model Number

JJ55H

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

-

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

1736b325-3fd7-4b64-91c8-fcb6bb44e3e3

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

August 24, 2015

Package DI Number

30705036003889

Quantity per Package

20

Contains DI Package

20705036003882

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE