FDA.reportPublic FDA data

FullFire® Select Diffusing Tip Laser Probe

Primary DI
00816589020465
Brand
FullFire® Select Diffusing Tip Laser Probe
Company
MONTERIS MEDICAL INC
Model
20624-00
Catalog number
FFS002-01
Device description
2.2mm Diffusing Tip Laser Probe
Published
2017-03-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143457000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143457000NeuroBlate SystemMonteris Medical, Inc.2015-02-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816589020465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816589020465008165890204658165890204650816589020465

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
Device Size Text, specify0
Outer Diameter2.2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)799-7655info@monteris.com

Regulatory Flags#

DUNS number
021415875
Device count
1
Serial number
true

Other Devices From This Company#

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00816589021622Brasseler Twist Drillbit21345213452026-07-03
00816589021608Mini-Bolt Accessory Kit21180CMB000-AA2026-02-23
00816589021219Fiducial Marker, Sterile212512025-02-07
00816589021202Mini-Bolt System29008CMB016-AA-R2024-11-12
00816589021226Mini-Bolt System21247CMB-ST2024-08-08
00816589021196Mini-Bolt System21155CMBVUE-UP2024-05-20
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser Probe22002FFD-0162024-01-02
00816589021189Mini-Bolt System21228CMB-VX2024-03-21
00816589021158Mini-Bolt System21224CMB016-AA2023-12-20
00816589021561Mini-Bolt System21165CMB016-S2023-12-20
00816589021578Mini-Bolt System21209CMB016-UP2023-12-20
00816589021592Mini-Bolt System22004CMB016-MS2023-12-20
00816589021165Mini-Bolt System21237CMB022-VA2023-09-10
00816589021172Mini-Bolt System21239CMB033-VA2023-09-10
00816589021240AtamA System20648ASA0012022-12-14
00816589021257Mini-Bolt System20755CMB0222022-12-14
00816589021264Mini-Bolt System20820208202022-12-14
00816589021271Mini-Bolt System20821208212022-12-14
00816589021288Mini-Bolt System21065210652022-12-14

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Primary DI, Brand, Company table
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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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