Catalog Number

6R45M

Brand Name

ENDOPATH

Version/Model Number

6R45M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 22, 2017

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

aeea81f0-6fde-42a1-9860-93395e64a30e

Public Version Date

May 07, 2019

Public Version Number

4

DI Record Publish Date

August 24, 2015

Package DI Number

30705036000857

Quantity per Package

504

Contains DI Package

20705036000850

Package Discontinue Date

February 22, 2017

Package Status

Not in Commercial Distribution

Package Type

CASE