Catalog Number

-

Brand Name

GeniClip

Version/Model Number

350-000-103

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100090

Product Code

FZP

Product Code Name

Clip, Implantable

Public Device Record Key

ad7b691d-ecc4-4ee6-9b39-cfb7a5134c04

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

May 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-