Catalog Number

660-HT46C

Brand Name

Health-Tec Barrier Film

Version/Model Number

660-HT46C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160232,K160232,K160232

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

8d8e9bcd-e5f7-4548-ad5b-0f831cdf7d28

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 18, 2017

Package DI Number

D773660HT46C3

Quantity per Package

12

Contains DI Package

D773660HT46C1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-