Home GUDID 08503590070344 SmartTwist
Primary DI 08503590070344
Brand SmartTwist
Company CLEARPOINT NEURO, INC.
Model NGS-HD-01
Catalog number NGS-HD-01
Device description SmartTwist MRII Hand Drill
Published 2016-08-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name ORR Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ORR Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08503590070344 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08503590070344 08503590070344 8503590070344
GMDN Terms# Term, Definition table Term Definition Manual cranial rotary handpiece, single-use A manually-powered, hand-held, surgical device intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)], or for the removal of a bone flap for brain surgery. It is typically a drill brace or a housing containing bevelled and/or straight teethed gears rotated via a side handle, and a Jacobs chuck or gripping collet to attach an exchangeable rotating endpiece (e.g., a cranial drill, bur, trephine or perforator). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 40 Degrees Fahrenheit 90 Degrees Fahrenheit
Regulatory Flags# DUNS number 959181160 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850376007703 ClearPoint Clearpoint Neuro, Inc. ORR 2022-10-06 00850376007857 ClearPoint Clearpoint Neuro, Inc. ORR 2022-10-06 00850359007003 ClearPoint Clearpoint Neuro, Inc. ORR 2022-03-09 00850376007758 SmartFrame Clearpoint Neuro, Inc. ORR 2022-01-31 00850376007598 SmartFrame Array Clearpoint Neuro, Inc. ORR 2021-07-14 00850376007604 Array Clearpoint Neuro, Inc. ORR 2021-07-14 00850376007628 Array Clearpoint Neuro, Inc. ORR 2021-07-14 00850376007635 Array Clearpoint Neuro, Inc. ORR 2021-07-14 00850359007744 ClearPoint Array Clearpoint Neuro, Inc. ORR 2021-04-07 00850359007911 ClearPoint Array Workstation Clearpoint Neuro, Inc. ORR 2021-04-07 00850359007959 SmartTip Clearpoint Neuro, Inc. ORR 2021-04-07 00850359007072 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007089 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007096 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007102 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007119 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007126 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007133 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007140 SmartGrid Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007157 ClearPoint Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007164 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007171 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007188 ClearPoint Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007195 ClearPoint Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007201 ClearPoint Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007218 ClearPoint Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007225 ClearPoint Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007232 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007249 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22 00850359007256 SmartFrame Clearpoint Neuro, Inc. ORR 2021-01-22
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