FDA.reportPublic FDA data

MRI-guided laser interstitial thermal therapy system beam guide

Definition
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.
GUDID devices
85
Last updated
2024-01-10 07:49:33

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816589021585NeuroBlate NB3 FullFire™ 1.6 Laser ProbeMONTERIS MEDICAL INC220022024-01-02
00816589020014SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-002016-09-02
00816589020021SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-0002016-09-02
00816589020038SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-12016-09-02
00816589020045SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-22016-09-02
00816589020052SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-32016-09-02
00816589020069SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-42016-09-02
00816589020076SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-52016-09-02
00816589020106FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-002016-09-02
00816589020113FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-0002016-09-02
00816589020120FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-12016-09-02
00816589020137FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-22016-09-02
00816589020144FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-32016-09-02
00816589020151FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-42016-09-02
00816589020168FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-52016-09-02
00816589020243FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-002016-09-02
00816589020250FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-0002016-09-02
00816589020267FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-12016-09-02
00816589020274FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-22016-09-02
00816589020281FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-32016-09-02
00816589020298FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-42016-09-02
00816589020304FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-52016-09-02
00816589020427FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-52017-03-10
00816589020434FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-42017-03-10
00816589020441FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-52017-03-10
00816589020458FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-32017-03-10
00816589020465FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-002017-03-10
00816589020472FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-12017-03-10
00816589020489FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-0002017-03-10
00816589020496FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-32017-03-10
00816589020502FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-42017-03-10
00816589020519FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-22017-03-10
00816589020526FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-22017-03-10
00816589020533FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-12017-03-10
00816589020540SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-0002017-03-10
00816589020557SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-12017-03-10
00816589020564SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-002017-03-10
00816589020571SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-22017-03-10
00816589020588SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-42017-03-10
00816589020595SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-32017-03-10
00816589020601FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-002017-03-10
00816589020618FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-0002017-03-10
00816589020625SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-52017-03-10
00816589020663FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-32017-10-25
00816589020670FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-42017-10-25
00816589020687FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-22017-10-25
00816589020694FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-52017-10-25
00816589020700FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-12017-10-25
00816589020717FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-0002017-10-25
00816589020724FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-12017-10-25
00816589020731FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-22017-10-25
00816589020748FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-42017-10-25
00816589020755FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-002017-10-25
00816589020762FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-32017-10-25
00816589020779SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-12017-10-25
00816589020786SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-42017-10-25
00816589020793SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-002017-10-25
00816589020809FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-002017-10-25
00816589020816SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-0002017-10-25
00816589020823FullFire® Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20414-0002017-10-25
00816589020830SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-52017-10-25
00816589020847FullFire® Select Diffusing Tip Laser ProbeMONTERIS MEDICAL INC20624-52017-10-25
00816589020854SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-32017-10-25
00816589020861SideFire® Directional Laser ProbeMONTERIS MEDICAL INC20368-22017-10-25
00816589020878NeuroBlate Optic SideFire® Laser ProbeMONTERIS MEDICAL INC20891-002018-10-17
00816589020885NeuroBlate Optic SideFire® Laser ProbeMONTERIS MEDICAL INC20891-0002018-10-17
00816589020892NeuroBlate Optic SideFire® Laser ProbeMONTERIS MEDICAL INC20891-12018-10-17
00816589020908NeuroBlate Optic SideFire® Laser ProbeMONTERIS MEDICAL INC20891-22018-10-17
00816589020915NeuroBlate Optic SideFire® Laser ProbeMONTERIS MEDICAL INC20891-32018-10-17
00816589020922NeuroBlate Optic SideFire® Laser ProbeMONTERIS MEDICAL INC20891-42018-10-17
00816589020939NeuroBlate Optic SideFire® Laser ProbeMONTERIS MEDICAL INC20891-52018-10-17
00816589020946NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20893-002018-10-17
00816589020953NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20893-0002018-10-17
00816589020960NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20893-12018-10-17
00816589020977NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20893-22018-10-17
00816589020984NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20893-32018-10-17
00816589020991NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20893-42018-10-17
00816589021004NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20893-52018-10-17
00816589021011NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20895-002018-10-17
00816589021028NeuroBlate Optic FullFire® Laser ProbeMONTERIS MEDICAL INC20895-0002018-10-17