Catalog Number

1170-01

Brand Name

RePlay

Version/Model Number

1170-01

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

-

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

d750cfec-2ec3-4c03-aa05-44d4db217385

Public Version Date

March 22, 2019

Public Version Number

3

DI Record Publish Date

August 01, 2018

Package DI Number

10816734021481

Quantity per Package

5

Contains DI Package

00816734021484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case