Catalog Number

-

Brand Name

Single Use Repositionable Clip

Version/Model Number

HX-202UR

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

K123601,K123601

Product Code

PKL

Product Code Name

Hemostatic metal clip for the GI tract

Public Device Record Key

e9f1f4e7-1c30-4f02-85b2-fd82f32f3570

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170385947

Quantity per Package

5

Contains DI Package

04953170385940

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-