RelyX™ Unicem 2 Automix - 3M™ ESPE™ RelyX™ Unicem 2 Automix Self-Adhesive - 3M Deutschland GmbH

Duns Number:315731711

Device Description: 3M™ ESPE™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement A3 Opaque Shade Value Pack, 5 3M™ ESPE™ RelyX™ Unicem 2 Automix Self-Adhesive Resin Cement A3 Opaque Shade Value Pack, 56857

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More Product Details

Catalog Number

56857

Brand Name

RelyX™ Unicem 2 Automix

Version/Model Number

56857

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)

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

b37e4420-6d72-4ebb-b9b5-0de0a4847159

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

September 24, 2016

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