Premium Plus - Denture Bath - Premium Plus International Limited

Duns Number:668367758

Device Description: Denture Bath

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More Product Details

Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

603-YELLOW

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

-

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

NNI

Product Code Name

Container, Specimen, Non-Sterile

Device Record Status

Public Device Record Key

ccae7207-2b38-408e-a5f7-25dd0547a9f5

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Additional Identifiers

Package DI Number

D838603YELLOW8

Quantity per Package

20

Contains DI Package

D838603YELLOW2

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