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

Device Identifier (DI) Information

NeuroBlate NB3 FullFire™ 1.6 Laser Probe
22002
In Commercial Distribution
FFD-016
MONTERIS MEDICAL INC
00816589021585
GS1

1
021415875 *Terms of Use
NeuroBlate NB3 FullFire™ Diffusing Tip 1.6 Laser Probe
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
ONO Neurosurgical Laser With Mr Thermography
HAW Neurological Stereotaxic Instrument
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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 1.6 Millimeter
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Device Record Status

f2b51fbe-367c-43d8-849c-fe881698a106
April 03, 2024
2
January 02, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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