Catalog Number

NB102

Brand Name

NeuroBlate® System

Version/Model Number

20360

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 29, 2017

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

52de9f0b-9dbc-4f5c-83d9-954afbe23456

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-