L C B Y .3MM SPOOL - IVOCLAR VIVADENT, INC.

Duns Number:176935203

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More Product Details

Catalog Number

584139

Brand Name

L C B Y .3MM SPOOL

Version/Model Number

584139

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 12, 2018

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)

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

EJT

Product Code Name

ALLOY, GOLD-BASED NOBLE METAL

Device Record Status

Public Device Record Key

15f0fe4c-c065-4dfa-9bca-704a0217155c

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

January 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IVOCLAR VIVADENT, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 485