Premium Plus - IMPRESSION TRAYS - Premium Plus International Limited

Duns Number:668367758

Device Description: IMPRESSION TRAYS

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More Product Details

Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

410

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

EHY

Product Code Name

Tray, Impression, Preformed

Device Record Status

Public Device Record Key

982b6070-4ce9-4d92-a110-e1dda659a55b

Public Version Date

January 08, 2020

Public Version Number

1

DI Record Publish Date

December 31, 2019

Additional Identifiers

Package DI Number

D8384108

Quantity per Package

4

Contains DI Package

D8384106

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