Catalog Number

DC0165

Brand Name

DuraClip

Version/Model Number

DC0165

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"

Yes

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

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

7925033c-70c7-4ab2-812c-1e2c053a8ef8

Public Version Date

December 19, 2018

Public Version Number

4

DI Record Publish Date

July 11, 2016

Package DI Number

36932619740020

Quantity per Package

10

Contains DI Package

26932619740023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case