Impregum™ Penta™ Super Quick - 3M™ Impregum™ Penta™ Super Quick MB Introductory - 3M Deutschland GmbH

Duns Number:315731711

Device Description: 3M™ Impregum™ Penta™ Super Quick MB Introductory Kit Dual, 69414

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More Product Details

Catalog Number

69414

Brand Name

Impregum™ Penta™ Super Quick

Version/Model Number

69414

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

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

EFD

Product Code Name

AMALGAMATOR, DENTAL, AC-POWERED

Device Record Status

Public Device Record Key

f85894e0-ebfd-4566-a522-891cf1bee6b1

Public Version Date

September 22, 2020

Public Version Number

4

DI Record Publish Date

November 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M DEUTSCHLAND GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 232
2 A medical device with a moderate to high risk that requires special controls. 563
U Unclassified 3