Catalog Number

CD6300P

Brand Name

CORE DYNAMICS

Version/Model Number

CD6300P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 27, 2021

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

Yes

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

FBM

Product Code Name

Cannula and trocar, suprapubic, non-disposable

Public Device Record Key

e2445f9d-40f0-4ef0-bdbb-1551c711c5b7

Public Version Date

July 27, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10653405045885

Quantity per Package

10

Contains DI Package

20653405045882

Package Discontinue Date

July 27, 2021

Package Status

Not in Commercial Distribution

Package Type

BOX