Home GUDID 00628341521390 7D Surgical Universal Array (6)
Primary DI 00628341521390
Brand 7D Surgical Universal Array (6)
Company 7D Surgical ULC
Model 11-0142
Published 2025-07-28
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 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 00628341521390 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 00628341521390 00628341521390 628341521390 0628341521390
GMDN Terms# Term, Definition table Term Definition Optical surgical tracking system spatial marker connector A component of a surgical navigation and/or tracking system (e.g., optical/electromagnetic device tracking system, computer-assisted neurosurgical ultrasound navigation system) intended to connect the system’s spatial marker [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 another marker; 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
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 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 00628341521383 7D Surgical Universal Array (5) 11-0141 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 - ø5.5mm - 150mm 11-0052 2020-10-21
Other Devices Sharing Product Codes#