Home GUDID 00190776375553 Millennium
Primary DI 00190776375553
Brand Millennium
Company Avalign Technologies, Inc.
Model 63-261041
Device description Hudson Brace with Snap-Lock Chuck
Published 2023-09-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 00190776375553 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190776375553 00190776375553 190776375553 0190776375553
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 792528510 Device count 1 Premarket exempt true Lot or batch true 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 Bunnell ASPEN SURGICAL PRODUCTS, 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 G586N8761820 Novo Surgical NOVO SURGICAL, INC. HBD 2023-12-18 G586N8761880 Novo Surgical NOVO SURGICAL, INC. HBD 2023-12-18 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 10381780494997 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-10-24 10381780495000 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-10-24 10381780495017 Integra® Miltex® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-10-24 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 10381780189459 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-04-02 M2742951161 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-04-02 10381780185314 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-01-31 10381780190097 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-01-31 10381780190158 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION HBD 2018-01-31 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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