Home GUDID 00628341521352 FLASH EVD System
Primary DI 00628341521352
Brand FLASH EVD System
Company 7D Surgical ULC
Model 10-0002
Published 2026-04-08
Public version status Update
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 HAW Neurological Stereotaxic Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HAW Neurological Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00628341521352 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 00628341521352 00628341521352 628341521352 0628341521352
GMDN Terms# Term, Definition table Term Definition Optical surgical navigation/tracking system A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures; it may be intended to overlay pre-acquired radiological images or real-time data [e.g., ultrasound (US)] for surgical navigation, and be capable of creating digital 3-D patient models. It consists of a workstation with controls/display, position/movement tracking cameras (e.g., infrared), adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ENT, neurosurgery, CMF surgery].
Regulatory Flags# DUNS number 204326292 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00628341520829 7D Surgical FLASH EVD Procedural Kit 11-0072 2026-04-08 00628341520836 7D Surgical FLASH EVD Non-Sterile Kit 11-0073 2026-04-08 00628341520843 7D Surgical FLASH EVD Sterile Kit 11-0074 2026-04-08 00628341521383 7D Surgical Universal Array (5) 11-0141 2025-07-28 00628341521390 7D Surgical Universal Array (6) 11-0142 2025-07-28 00628341520850 7D Surgical Reference Clamp (Gator) 11-0096 2023-01-12 00628341521024 7D Surgical Flex Rod Connector (4.5 mm - 100 mm) 11-0113 2023-08-18 00628341520874 7D Surgical Spine Reference Clamp (Multi-Level) 11-0098 2023-07-31 00628341520799 7D Surgical Pedicle Probe (Slim) 11-0092 2022-09-21 00628341520805 7D Surgical Universal Array 3 11-0093 2022-09-21 00628341520812 7D Surgical Universal Array 4 11-0094 2022-09-21 00628341520577 7D Surgical Universal Clamp (Stryker Adapter) 11-0067 11-0067 2020-11-18 00628341520690 7D Surgical Universal Clamp (SeaSpine Adapter) 11-0079 2022-01-11 00628341520706 7D Surgical Inserter, Lumbar 11-0085 2021-12-31 00628341520713 7D Surgical Navigation Guide, T-Handle 11-0086 2021-12-31 00628341520720 7D Surgical Facet Array Adaptor 11-0087 2021-12-31 00628341520560 7D Surgical Pedicle Probe (Sharp) 11-0055 2021-02-12 00628341520522 7D Surgical Spine Reference Clamp (Radiolucent) 11-0057 2021-01-06 00628341520478 7D Surgical Flex Array 11-0053 2020-10-21 00628341520485 11-0052 7D Flex Rod Connector - ΓΈ5.5mm - 150mm 11-0052 2020-10-21
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07340201503829 Leksell Neurosurgical Instruments Elekta Solutions AB HAW 2026-10-20 07340201503836 Leksell Neurosurgical Instruments Elekta Solutions AB HAW 2026-10-20 07340201503843 Leksell Neurosurgical Instruments Elekta Solutions AB HAW 2026-10-20 07340201503850 Leksell Neurosurgical Instruments Elekta Solutions AB HAW 2026-10-20 07340201503867 Leksell Neurosurgical Instruments Elekta Solutions AB HAW 2026-10-20 07340201503812 Leksell Neurosurgical Instruments Elekta Solutions AB HAW 2026-10-19 06974813832681 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832698 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832704 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832711 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832728 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832735 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832742 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832759 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832766 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832773 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832780 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832797 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832810 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832827 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832834 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 06974813832841 NA Sinovation (Beijing) Medical Technology Co., Ltd HAW 2026-09-29 00889024713895 ROSA ONE BRAIN APPLICATION (US) MEDTECH HAW 2026-09-28 00889024714113 PLANNING STATION - USA MEDTECH HAW 2026-09-28 00199150071968 Stealth AXiS Leica Kit MEDTRONIC NAVIGATION, INC. HAW 2026-09-25 00199150071975 Stealth AXiS Kinevo 900 Kit MEDTRONIC NAVIGATION, INC. HAW 2026-09-25 00199150071982 Stealth AXiS Pentero 900 Kit MEDTRONIC NAVIGATION, INC. HAW 2026-09-25 00850088866001 CBYON MED-SURGICAL SERVICES, INC. HAW 2026-09-25 00199150054404 ZEISS TIVATO 700 MEDTRONIC NAVIGATION, INC. HAW 2026-09-21 00199150054442 ZEISS PENTERO 800S MEDTRONIC NAVIGATION, INC. HAW 2026-09-21