Imprint™ 4 Super Quick Heavy - 3M™ ESPE™ Imprint™ 4 Super Quick Heavy VPS - 3M Deutschland GmbH

Duns Number:315731711

Device Description: 3M™ ESPE™ Imprint™ 4 Super Quick Heavy VPS Impression Material Intro Kit, 71535

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More Product Details

Catalog Number

71535

Brand Name

Imprint™ 4 Super Quick Heavy

Version/Model Number

71535

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

EID

Product Code Name

SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Device Record Status

Public Device Record Key

71ab7f57-0349-4af1-a31c-aaf846520d64

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

August 04, 2017

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