Catalog Number

-

Brand Name

HEARTLINE GEMINI DISSECTING FORCEPS

Version/Model Number

2800-7828S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2018

Issuing Agency

In HIBCC

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"

-

For Single-Use

-

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

K152400

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

f4f11960-0765-4453-b7fb-04b9af2d9c9d

Public Version Date

July 06, 2018

Public Version Number

6

DI Record Publish Date

August 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-