AccessGUDID - DEVICE: NeuroBlate NB3 FullFire™ 1.6 Laser Probe (00816589021585)

GUDID

Device Identifier (DI) Information

Brand Name: NeuroBlate NB3 FullFire™ 1.6 Laser Probe
Version or Model: 22002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FFD-016
Company Name: MONTERIS MEDICAL INC

Primary DI Number: 00816589021585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021415875 *Terms of Use

Device Description: NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe

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?
62268	MRI-guided laser interstitial thermal therapy system beam guide	A sterile, invasive, probe-like device intended to be used in conjunction with an MRI-guided laser interstitial thermal therapy (LITT) system to direct and deliver laser energy for ablation of soft-tissue brain lesions. It is stereotactically placed by a neurosurgeon, using minimally-invasive techniques, and is manoeuvred during laser therapy by a remotely-controlled robotic arm/driver. It typically consists of fibreoptic materials with a laser-firing distal end. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument
ONO	Neurosurgical Laser With Mr Thermography
HAW	Neurological Stereotaxic Instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Special Storage Condition, Specify: Keep Away from Sunlight
Special Storage Condition, Specify: Do not use if package is damaged

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.6 Millimeter

Device Record Status

Public Device Record Key: f2b51fbe-367c-43d8-849c-fe881698a106
Public Version Date: April 03, 2024
Public Version Number: 2
DI Record Publish Date: January 02, 2024