Home GUDID G586N8761820 Novo Surgical
Primary DI G586N8761820
Brand Novo Surgical
Company NOVO SURGICAL, INC.
Model N8761-82
Catalog number N8761-82
Device description moore drill, moore drill only
Published 2023-12-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HBD HANDPIECE (BRACE), DRILL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HBD Handpiece (Brace), Drill Neurology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G586N8761820 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Manual cranial rotary handpiece, reusable 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 reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 033029433 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00887482125229 Symmetry Surgical® SYMMETRY SURGICAL INC. HBD 2024-08-12 G586N6871060 Novo Surgical NOVO SURGICAL, INC. HBD 2023-12-18 G586N6872220 Novo Surgical NOVO SURGICAL, INC. HBD 2023-12-18 G586N8761800 Novo Surgical NOVO SURGICAL, INC. HBD 2023-12-18 G586N8761810 Novo Surgical NOVO SURGICAL, INC. HBD 2023-12-18 G586N8761880 Novo Surgical NOVO SURGICAL, INC. HBD 2023-12-18 00190776375553 Millennium Avalign Technologies, Inc. HBD 2023-09-08 00842331168611 Novo Surgical Inc. NOVO SURGICAL, INC. HBD 2022-11-13 00842331130731 Novo Surgical Inc. NOVO SURGICAL, INC. HBD 2022-11-10 00842331136108 Novo Surgical Inc. NOVO SURGICAL, INC. HBD 2022-11-10 04038653068821 MACRO-LINE Aesculap AG HBD 2020-08-24 04038653069460 AESCULAP Aesculap AG HBD 2020-05-08 04038653162956 AESCULAP Aesculap AG HBD 2020-04-22 H83426240 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-10-24 H83426320 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-10-24 H83426350 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-10-24 M2742951161 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-04-02 M2742751351 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-01-31 M2742951111 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-01-31 M2742951171 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-01-31
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