Catalog Number

-

Brand Name

Deltec

Version/Model Number

21-2320-24

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

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

K112407,K112407

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

33214d3e-61ce-4878-b9ba-6996b6d092a2

Public Version Date

August 17, 2018

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

30610586025116

Quantity per Package

5

Contains DI Package

10610586025112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX