Catalog Number

ROCC-D-23-165

Brand Name

SureClip

Version/Model Number

ROCC-D-23-165

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

K152001,K152001,K152001

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

7d7a97a5-1479-49a2-ad89-7a7eab40ec72

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 10, 2016

Package DI Number

26932503530013

Quantity per Package

10

Contains DI Package

16932503530016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case