Luxisse - YTTRIA STABILIZED ZIRCONIA - HEANY INDUSTRIES, INC.

Duns Number:002221091

Device Description: YTTRIA STABILIZED ZIRCONIA

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More Product Details

Catalog Number

MDDK3740ZF12A35

Brand Name

Luxisse

Version/Model Number

0

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

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

60914765-4fdd-4bbe-a537-72f88eafb498

Public Version Date

September 25, 2020

Public Version Number

1

DI Record Publish Date

September 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEANY INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 595