AccessGUDID - DEVICE: NeuroBlate® Advanced Probe Driver (00816589020083)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroBlate® Advanced Probe Driver
Version or Model: 20369
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NBD-01
Company Name: MONTERIS MEDICAL INC

Primary DI Number: 00816589020083
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 021415875 *Terms of Use

Device Description: Probe Driver - AXiiiS (Long)

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62269	MRI-guided laser interstitial thermal therapy system beam guide driver	A sterile robotic device intended to be used in conjunction with an MRI-guided laser interstitial thermal therapy (LITT) system to facilitate remote manoeuvring of an invasive laser beam guide during laser therapy to ablate soft-tissue brain lesions. It is noninvasively attached to the skull (typically via a stereotactic frame or an implanted skull anchor) whereby it rotates and translates a connected laser beam guide. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Axiiis (Long)

Device Record Status

Public Device Record Key: 79ad7c98-399c-4944-b86f-a6d219df17f7
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: September 02, 2016