Home GUDID 00628341520713 7D Surgical Navigation Guide, T-Handle
Primary DI 00628341520713
Brand 7D Surgical Navigation Guide, T-Handle
Company 7D Surgical ULC
Model 11-0086
Published 2021-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name OLO Orthopedic Stereotaxic Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLO Orthopedic Stereotaxic Instrument Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00628341520713 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 00628341520713 00628341520713 628341520713 0628341520713
GMDN Terms# Term, Definition table Term Definition Optical surgical navigation device tracking system spatial register connector A non-sterile component of a surgical navigation device tracking system (e.g., optical device tracking system, electromagnetic device tracking system) intended to connect the system’s spatial register [localizer/tracker/calibrator (e.g., infrared light reflector)] to a navigated surgical instrument (e.g., a stereotactic surgery system probe, dental drill), and/or to a navigation fiducial marker, during computer assisted surgery (CAS); it may be affixed via dedicated screws. It is typically made of metallic or polymer materials and may be in the shape of a handle to facilitate handling the instrument during a procedure. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 204326292 Device count 1 Lot or batch true Manufacturing date on label true Sterilization required before use 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 00628341520843 7D Surgical FLASH EVD Sterile Kit 11-0074 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
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