Catalog Number

CD6GKP

Brand Name

CORE DYNAMICS

Version/Model Number

CD6GKP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 06, 2022

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"

-

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

K950457,K950457,K950457

Product Code

HET

Product Code Name

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

31a7a1f4-5a5e-4cbb-aba0-95936939e8a4

Public Version Date

June 07, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10653405045946

Quantity per Package

5

Contains DI Package

20653405045943

Package Discontinue Date

June 06, 2022

Package Status

Not in Commercial Distribution

Package Type

BOX