FDA.reportPublic FDA data

FullFire® Select Diffusing Tip Laser Probe

Primary DI
00816589020243
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
2016-09-02
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
00816589020243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816589020243008165890202438165890202430816589020243

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

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