Catalog Number

-

Brand Name

ClearEndoclip

Version/Model Number

FM-CLD11-090(1650)

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

K200217,K200217

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

7892d9ee-1a8a-4989-90cb-14a3c672fbb9

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Package DI Number

18809327353085

Quantity per Package

5

Contains DI Package

08809327353088

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box