Home GUDID 00628341520843 7D Surgical FLASH EVD Sterile Kit
Primary DI 00628341520843
Brand 7D Surgical FLASH EVD Sterile Kit
Company 7D Surgical ULC
Model 11-0074
Published 2026-04-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true 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 00628341520843 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 00628341520843 00628341520843 628341520843 0628341520843
GMDN Terms# Term, Definition table Term Definition Surgical optical-tracking spatial marker, single-use A non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a single-use device.
Regulatory Flags# DUNS number 204326292 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true 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 00628341521352 FLASH EVD System 10-0002 2026-04-08 00628341521406 7D Surgical Universal Tracking Sterilization Tray 11-0143 2025-09-17 00628341521383 7D Surgical Universal Array (5) 11-0141 2025-07-28 00628341521390 7D Surgical Universal Array (6) 11-0142 2025-07-28 00628341520904 7D Surgical Iliac Cross Pin, 100 mm 11-0101 2023-02-21 00628341520935 7D Surgical Iliac Cross Pin, 150 mm 11-0104 2023-02-21 00628341520188 7D Surgical Steinmann Pin (ø3.2mm x 150mm) 11-0031 2021-07-27 00628341520195 7D Surgical Steinmann Pin (ø4.0mm x 150mm) 11-0032 2021-07-27 00628341521055 7D Surgical Iliac Dual Pin Sterilization Tray 11-0125 2024-07-19 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
Other Devices Sharing Product Codes#