Ketac™ Universal Aplicap™ - 3M™ ESPE™ Ketac™ Universal Aplicap™ Giant Pack - 3M Deutschland GmbH

Duns Number:315731711

Device Description: 3M™ ESPE™ Ketac™ Universal Aplicap™ Giant Pack A3, 300 Capsules, 61097

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More Product Details

Catalog Number

61097

Brand Name

Ketac™ Universal Aplicap™

Version/Model Number

61097

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

Yes

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

EMA

Product Code Name

CEMENT, DENTAL

Device Record Status

Public Device Record Key

8c73c5c2-6928-461e-8dc6-daa0f8f8f32d

Public Version Date

September 21, 2018

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