Catalog Number

392403

Brand Name

Obturator

Version/Model Number

392403

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"

-

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

K894157,K894157

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

18ccbdb9-a8be-4b15-939c-d2b09baa6554

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20886333210491

Quantity per Package

50

Contains DI Package

00886333210497

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box