Catalog Number

-

Brand Name

Single Use Repositionable Clip

Version/Model Number

HX-202UR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 2022

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

K123601,K123601

Product Code

PKL

Product Code Name

Hemostatic metal clip for the GI tract

Public Device Record Key

c1f4aedd-dc21-49f5-9a15-885e2cf3b608

Public Version Date

August 16, 2022

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

14953170345187

Quantity per Package

10

Contains DI Package

04953170345180

Package Discontinue Date

August 15, 2022

Package Status

Not in Commercial Distribution

Package Type

-