Catalog Number

1214-03D

Brand Name

SafeGuide®

Version/Model Number

1214-03D

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

-

Product Code

KNQ

Product Code Name

Dilator, Esophageal

Public Device Record Key

5dff36e4-513b-4c4f-b091-f2058784b5e3

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

September 17, 2016

Package DI Number

10816734020996

Quantity per Package

3

Contains DI Package

00816734020999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case