Catalog Number

-

Brand Name

Single Use Reloadable Clip Applicator

Version/Model Number

HX-810UR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

K183590,K183590

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

60de5645-3a56-462c-9390-e3b7b6012e95

Public Version Date

December 17, 2021

Public Version Number

6

DI Record Publish Date

October 09, 2019

Package DI Number

14953170421348

Quantity per Package

10

Contains DI Package

04953170421341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-