Catalog Number

GEM1521

Brand Name

GEM

Version/Model Number

GEM1521

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"

-

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

0f02f24d-c561-4970-8b67-cbc01ad192ca

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

July 31, 2019

Package DI Number

13661522039448

Quantity per Package

30

Contains DI Package

03661522039441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-