Catalog Number

-

Brand Name

i700 Single use tip

Version/Model Number

MD-ST0200

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

-

Product Code

NOF

Product Code Name

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Public Device Record Key

3f78305a-acd6-4865-bff8-cc2af49aad3c

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

November 15, 2021

Package DI Number

18800026700057

Quantity per Package

30

Contains DI Package

08800026700050

Package Discontinue Date

November 15, 2021

Package Status

Not in Commercial Distribution

Package Type

-