Catalog Number

6R45B

Brand Name

ENDOPATH

Version/Model Number

6R45B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

e80412e6-50a9-4680-ae24-c3015bad8e44

Public Version Date

October 16, 2019

Public Version Number

5

DI Record Publish Date

August 24, 2015

Package DI Number

30705036000840

Quantity per Package

504

Contains DI Package

10705036000846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE