Plasdent - Sticky Applicator - White - PLASDENT CORPORATION

Duns Number:190377184

Device Description: Sticky Applicator - White

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More Product Details

Catalog Number

8303-1

Brand Name

Plasdent

Version/Model Number

8303-1

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

-

Product Code Details

Product Code

KXF

Product Code Name

Applicator, Absorbent Tipped, Non-Sterile

Device Record Status

Public Device Record Key

3e73db76-11a5-4262-aec3-fbc0cd48a654

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PLASDENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 750
2 A medical device with a moderate to high risk that requires special controls. 36