Catalog Number

DIL-615-52

Brand Name

Dilator

Version/Model Number

DIL-615-52

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

-

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

610c2a29-56aa-421c-ab80-240842c22ab3

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

August 09, 2017

Package DI Number

20841268107049

Quantity per Package

100

Contains DI Package

10841268107042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box