DENTEK CMF CLEAN 75CT FLOSS PICK 24 - DENTEK COMFORT CLEAN 75CT FLOSS PICK 24 - MEDTECH PRODUCTS INC.

Duns Number:060272465

Device Description: DENTEK COMFORT CLEAN 75CT FLOSS PICK 24

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More Product Details

Catalog Number

-

Brand Name

DENTEK CMF CLEAN 75CT FLOSS PICK 24

Version/Model Number

40047701002719

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

JES

Product Code Name

Floss, Dental

Device Record Status

Public Device Record Key

7dd0d9fc-60f9-4c05-b6aa-9f82be311a85

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Additional Identifiers

Package DI Number

40047701002719

Quantity per Package

75

Contains DI Package

00047701002711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multiple

"MEDTECH PRODUCTS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 6
U Unclassified 14