NeuroBlate® Robotic Probe Driver - Probe Driver - Bolt (Short) - MONTERIS MEDICAL INC

Duns Number:021415875

Device Description: Probe Driver - Bolt (Short)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

RPD-01

Brand Name

NeuroBlate® Robotic Probe Driver

Version/Model Number

20772

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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 Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

d3e9c17f-1356-4d06-8918-d0a60b81316a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MONTERIS MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 111