DENTEK CROSS FLOSSER 75CT FLS PICK 36 - DENTEK CROSS FLOSSER 75CT FLS PICK 36 - MEDTECH PRODUCTS INC.

Duns Number:060272465

Device Description: DENTEK CROSS FLOSSER 75CT FLS PICK 36

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More Product Details

Catalog Number

-

Brand Name

DENTEK CROSS FLOSSER 75CT FLS PICK 36

Version/Model Number

20047701000711

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

7fd49949-f0a7-4882-8794-486b3385923e

Public Version Date

October 31, 2022

Public Version Number

1

DI Record Publish Date

October 21, 2022

Additional Identifiers

Package DI Number

20047701000711

Quantity per Package

75

Contains DI Package

00047701000717

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