Catalog Number

-

Brand Name

Smart Advantage GI A1 and A2 Combo kit 30 ampules

Version/Model Number

675COMB00

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K895386,K895386,K895386

Product Code

EMA

Product Code Name

Cement, Dental

Public Device Record Key

734a03c8-0242-48da-8e27-951e2129c1f3

Public Version Date

October 22, 2019

Public Version Number

1

DI Record Publish Date

October 14, 2019

Package DI Number

00858290006437

Quantity per Package

15

Contains DI Package

00858290006352

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

kit