Premium Plus - Dental oral evacuators - Premium Plus International Limited

Duns Number:668367758

Device Description: Dental oral evacuators

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More Product Details

Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

301-ASS

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

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

3bfea0d4-ce28-46af-ac12-27bb2a93ad0d

Public Version Date

January 02, 2020

Public Version Number

1

DI Record Publish Date

December 25, 2019

Additional Identifiers

Package DI Number

D838301ASS8

Quantity per Package

4

Contains DI Package

D838301ASS2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"PREMIUM PLUS INTERNATIONAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 166
2 A medical device with a moderate to high risk that requires special controls. 13