Catalog Number

-

Brand Name

GeniClip Open Applier

Version/Model Number

330-005-004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HBT

Product Code Name

Applier, Hemostatic Clip

Public Device Record Key

f5e9dd6c-4024-4eb2-8e76-ff62c0368bb6

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

May 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-