FDA.reportPublic FDA data

NeuroBlate NB3 FullFire™ 1.6 Laser Probe

Primary DI
00816589021585
Brand
NeuroBlate NB3 FullFire™ 1.6 Laser Probe
Company
MONTERIS MEDICAL INC
Model
22002
Catalog number
FFD-016
Device description
NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe
Published
2024-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
HAWNeurological Stereotaxic Instrument
ONONeurosurgical Laser With Mr Thermography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HAWNeurological Stereotaxic InstrumentNeurology2
ONONeurosurgical Laser With Mr ThermographyGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816589021585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816589021585008165890215858165890215850816589021585

GMDN Terms#

Term, Definition table
TermDefinition
MRI-guided laser interstitial thermal therapy system beam guideA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter1.6Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Special Storage Condition, Specify00Keep Away from Sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021415875
Device count
1
Premarket exempt
true
Serial number
true
Expiration date on label
true

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00816589021240AtamA System20648ASA0012022-12-14
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00816589021288Mini-Bolt System21065210652022-12-14
00816589021295Mini-Bolt System20802208022022-12-14
00816589021301Mini-Bolt System21154CMB022-AA-R2022-12-14
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