Catalog Number

-

Brand Name

Single Use Reloadable Clip Applicator

Version/Model Number

HX-810LR

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 15, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183590,K183590

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

a3ce03eb-babe-4808-8009-dfbf41fc8bc9

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

December 17, 2021

Package DI Number

14953170390699

Quantity per Package

10

Contains DI Package

04953170390692

Package Discontinue Date

August 15, 2022

Package Status

Not in Commercial Distribution

Package Type

-