Health-Tec Light Handle Sleeves - Health-Tec Light Handle Sleeves, 4" x 5.75" - Dental Health Products Inc

Duns Number:623191194

Device Description: Health-Tec Light Handle Sleeves, 4" x 5.75"

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More Product Details

Catalog Number

660-HT4575

Brand Name

Health-Tec Light Handle Sleeves

Version/Model Number

660-HT4575

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Device Record Status

Public Device Record Key

e46519ce-920f-46ad-8542-9daf263c65de

Public Version Date

November 22, 2018

Public Version Number

4

DI Record Publish Date

January 24, 2017

Additional Identifiers

Package DI Number

D773660HT45753

Quantity per Package

36

Contains DI Package

D773660HT45751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DENTAL HEALTH PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 464
2 A medical device with a moderate to high risk that requires special controls. 78