Catalog Number

-

Brand Name

Clip

Version/Model Number

HX-610-090

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

K183590,K183590

Product Code

PKL

Product Code Name

Hemostatic metal clip for the GI tract

Public Device Record Key

8f484ce6-a962-41d2-8dc2-0ee78dd5428c

Public Version Date

December 17, 2021

Public Version Number

5

DI Record Publish Date

October 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-