Catalog Number

-

Brand Name

LUXEN Zr

Version/Model Number

LUXEN 1100-12T-D98-MC1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171585

Product Code

EIH

Product Code Name

Powder, Porcelain

Public Device Record Key

52373266-d10c-4e25-93c7-e43a794a7be5

Public Version Date

May 16, 2019

Public Version Number

1

DI Record Publish Date

May 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-