Catalog Number

-

Brand Name

Surgic Pro+

Version/Model Number

Surgic Pro+ OPT-D(120V)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 25, 2018

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

EBW

Product Code Name

CONTROLLER, FOOT, HANDPIECE AND CORD

Public Device Record Key

d2bfb28e-aae6-4314-bbdf-0c4b115a687a

Public Version Date

August 29, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-