Catalog Number

GEM1521

Brand Name

GEM-CLIP

Version/Model Number

GEM1521

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2016

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"

-

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

FZP

Product Code Name

Clip, Implantable

Public Device Record Key

58c0ca8c-fde8-486c-a7cd-db1892c4d79a

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2015

Package DI Number

03661624005870

Quantity per Package

30

Contains DI Package

03661624005863

Package Discontinue Date

June 01, 2016

Package Status

Not in Commercial Distribution

Package Type

clinical box