Catalog Number

50-5010

Brand Name

STELLAR ATTACHMENT RESIN

Version/Model Number

PINK - 4 MIN SET - Evaluator

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

EBH

Product Code Name

Material, Impression Tray, Resin

Public Device Record Key

d4ac698e-2652-4b05-910a-c7d6f6529b54

Public Version Date

September 13, 2019

Public Version Number

1

DI Record Publish Date

September 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-