PMT CORPORATION - STEREOTACTIC

GUDID 00650551147060

SPLIT BUSHING FOR ROSA SEEG DEPTH PLACEMENT

PMT CORPORATION

Neurological stereotactic surgery system
Primary Device ID00650551147060
NIH Device Record Key64fbbf7e-61aa-478c-8ba6-823cb3e7cb6e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMT CORPORATION - STEREOTACTIC
Version Model Number2103-193
Company DUNS039576871
Company NamePMT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100650551147060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


[00650551147060]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-20
Device Publish Date2021-07-12

On-Brand Devices [PMT CORPORATION - STEREOTACTIC]

00650551068372ROSA sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-60, 2103-68, 2103-69, 2103-85, 2103-92, 2103-93, 2
00650551068365BRW/CRW KIT: 2103-26, 2103-33, 2103-40, 2103-45, 2103-47, 2103-51, FOR 3.2MM DRILL
00650551068358BRW/CRW-sEEG KIT: 2103-17, 2103-34 (QTY 2), 2103-52, 2103-92, 2103-60, 2103-68, 2103-69, 2103-85
00650551068341STEALTH DEPTH KIT: 2103-38, 2103-01, 2103-02, FOR 3.2MM DRILL
00650551068334STEALTH sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-92, 2103-60, 2103-68, 2103-69, 2103-71, 2103-85
00650551068327VERTEK sEEG KIT: 2103-114, 2103-95 (QTY 2), 2103-52, 2103-92, 2103-63, 2103-66, 2103-69, 2103-65
00650551068310STEALTH sEEG KIT: 2103-95 (QTY 2), 2103-52, 2103-92, 2103-63, 2103-66, 2103-69, 2103-42, 2103-65
00650551068303LEKSELL sEEG KIT: 2103-95 (QTY 2), 2103-52, 2103-92, 2103-63, 2103-65, 2103-66, 2103-69, 2103-10
00650551068297BRW/CRW-sEEG KIT: 2103-36, 2103-95 (QTY 2), 2103-52, 2103-92, 2103-63, 2103-66, 2103-69, 2103-65
00650551068280ROSA sEEG KIT: 2103-52, 2103-63, 2103-65, 2103-66, 2103-69, 2103-92, 2103-95 (QTY 2), FOR 2.4MM
00650551068273STEALTH DEPTH KIT: 2103-38, 2103-31, 2103-02, FOR 2.7MM DRILL
00650551068266LEKSELL KIT: 2103-39, 2103-26, 2103-58, 2103-59, 2103-62, 2103-61, 2103-73, 2103-74, FOR 2.7MM D
00650551068259BRAINLAB sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-60, 2103-64, 2103-68, 2103-69, 2103-85, 2103-9
00650551068242BRAINLAB KIT: 2103-80, 2103-102, 2103-103, FOR 3.2MM DRILL
00650551068235VERTEK sEEG KIT: 2103-03, 2103-34 (QTY 2), 2103-52, 2103-92, 2103-60, 2103-68, 2103-69, 2103-85,
00650551068228BRAINLAB sEEG KIT: 2103-95 (QTY 2), 2103-52, 2103-63, 2103-66, 2103-69, 2103-92, 2103-65, 2103-1
00650551068211VERTEK KIT: 2103-05, 2103-102, 2103-103, FOR 3.2MM DRILL
00650551068204BRAINLAB KIT: 2103-56, 2103-102, 2103-103, FOR 2.7MM DRILL
00650551068198VERTEK KIT: 2103-101, 2103-102, 2103-103, FOR 2.7MM DRILL
00650551068181LEKSELL KIT: 2103-39, 2103-26, 2103-58, 2103-59, 2103-62, 2103-61, 2103-76, 2103-77, FOR 3.2MM D
00650551068174BRW/CRW KIT: 2103-26, 2103-40, 2103-45, 2103-47, 2103-48, 2103-51, FOR 2.7MM DRILL
00650551068167LEKSELL sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-92, 2103-60, 2103-68, 2103-69, 2103-87, 2103-88
00650551046493sEEG ANCHOR BOLT, FOR 2.4MM DRILL
00650551046486sEEG ANCHOR BOLT, FOR 2.4MM DRILL
00650551046356TWIST DRILL BIT
00650551046349TWIST DRILL BIT
00650551039983SHIELDED TAIL
00650551039976LEKSELL-sEEG DRILL REDUCING TUBE, FOR 2.1MM DRILL
00650551039969sEEG BOLT DRIVER REDUCING TUBE
00650551039952sEEG DEPTH ANCHOR BOLT DRIVER, FOR ANCHOR BOLT 2103-29-XX
00650551039945BUSHING FOR DRIVER FOR ROSA ROBOT, FOR 2.1MM DRILL
00650551039938sEEG ANCHOR BOLT DRIVER, FOR ANCHOR BOLT 2103-15-XX
00650551039921DEPTH STOP FOR sEEG GUIDING STYLET, FOR ALL DRILL SIZES
00650551039914STYLET FOR DEPTHALON
00650551039907DEPTH STOP FOR ANCHOR BOLT, FOR 2.7MM DRILL
00650551039891DEPTH STOP FOR ANCHOR BOLT, FOR 3.2MM DRILL
00650551039884LEKSELL-sEEG DRIVER LOWER GUIDE BUSHING, FOR 2.1MM DRILL
00650551039877LEKSELL-sEEG DRIVER UPPER GUIDE BUSHING, FOR 2.1MM DRILL
00650551039860GUIDE FOR VISUALASE
00650551039853sEEG DEPTH DRILL GUIDE REDUCING TUBE, FOR 2.1MM DRILL
00650551039815DRILL GUIDE FOR BRAINLAB, FOR 3.2MM DRILL
00650551039808GUIDE TUBE, FOR 2.1MM DRILL
00650551039792STYLET WITH HUB, FOR 2.1MM AND 2.4MM DRILL
00650551039785LEKSELL-UPPER 3.2MM DRILL BUSHING, FOR 3.2MM DRILL
00650551039778LEKSELL-LOWER 3.2MM DRILL BUSHING, FOR 3.2MM DRILL
00650551039761sEEG DRILL REDUCING TUBE, FOR 2.1MM DRILL
00650551039754LEKSELL-UPPER 2.7MM DRILL BUSHING, FOR 2.7MM DRILL
00650551039747LEKSELL-LOWER 2.7MM DRILL BUSHING, FOR 2.7MM DRILL
00650551039730DEPTH STOP FOR DEPTHALON ANCHOR BOLT DRIVER
00650551039723STEALTH SYSTEM-sEEG DEPTH ANCHOR BOLT DRIVER BUSHING, FOR 2.1MM DRILL

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