Catalog Number

473011

Brand Name

EPITEX®

Version/Model Number

473011

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

EHM

Product Code Name

STRIP, POLISHING AGENT

Public Device Record Key

39c63fb3-22bd-4c6c-803f-3c3ab33f641d

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Package DI Number

20386040011331

Quantity per Package

5

Contains DI Package

10386040011334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-