Catalog Number

CD5055P-I

Brand Name

CORE DYNAMICS

Version/Model Number

CD5055P-I

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

Product Code

HET

Product Code Name

LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Public Device Record Key

2848a401-e103-4326-a53d-43fa3155b231

Public Version Date

September 28, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-