Catalog Number

-

Brand Name

TE-98 RM

Version/Model Number

10059810

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 05, 2019

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

-

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

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

95c65c43-b6a0-4f48-a12d-027f847a8f73

Public Version Date

June 05, 2019

Public Version Number

3

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-