Catalog Number

U-1102

Brand Name

One-Step

Version/Model Number

U-1102

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

-

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

EMA

Product Code Name

CEMENT, DENTAL

Public Device Record Key

d40f5a50-2888-4686-94c4-a521c6e981ac

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

10810111540947

Quantity per Package

1

Contains DI Package

00810111540940

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Item No: U-1102P