Catalog Number

D600SE110

Brand Name

Sensimatic™

Version/Model Number

D600SE110

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2018

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

EKZ

Product Code Name

Unit, Electrosurgical, And Accessories, Dental

Public Device Record Key

f929e28f-f7eb-4387-9250-0f6577c2efaa

Public Version Date

October 11, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-