Catalog Number

5400-01

Brand Name

Tango-Endo

Version/Model Number

5400-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 01, 2022

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

EKM

Product Code Name

GUTTA-PERCHA

Public Device Record Key

c8abb97f-56ee-4558-a57d-37677d202529

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

July 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-