Catalog Number

-

Brand Name

Premium Plus

Version/Model Number

080

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

EID

Product Code Name

Syringe, Restorative And Impression Material

Public Device Record Key

65b47293-557b-4611-8cee-7d38bef7cdb3

Public Version Date

January 15, 2020

Public Version Number

1

DI Record Publish Date

January 07, 2020

Package DI Number

D8380808

Quantity per Package

4

Contains DI Package

D8380806

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE