Catalog Number

1214-03R

Brand Name

SafeGuide®

Version/Model Number

1214-03R

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

-

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

aa151337-ecae-4b25-8d32-32e41feb0d61

Public Version Date

June 10, 2022

Public Version Number

8

DI Record Publish Date

September 17, 2016

Package DI Number

10816734021009

Quantity per Package

3

Contains DI Package

00816734021002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case