Home GUDID 00873263008553 Unibody™ Bone Fiducials (7mm)
Primary DI 00873263008553
Brand Unibody™ Bone Fiducials (7mm)
Company FHC, INC.
Model FM-4007-00855
Catalog number FM-4007
Device description Unibody™ Bone Fiducials (7mm) for use with the Nexframe® Sterotactic System
Published 2022-05-18
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
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 10873263008550 Primary GS1 0 10873263008758 Primary GS1 0 00873263008553 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10873263008550 10873263008550 10873263008758 10873263008758 00873263008553 00873263008553 873263008553 0873263008553
GMDN Terms# Term, Definition table Term Definition Neurological stereotactic surgery system An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -34 Degrees Celsius 57 Degrees Celsius
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 108179458 Device count 6 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true 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 00873263007693 microTargeting™ Insertion Tube 66-IT-IT2P-00769 66-IT-IT2P 2026-05-08 00873263007785 microTargeting™ Insertion Tube 66-IT(IT2)-00778 66-IT(IT2) 2026-05-08 00873263007792 microTargeting™ Insertion Tube 66-PT(IT2)-00779 66-PT(IT2) 2026-05-08 00873263003046 WayPoint™ Surgical Kit 66-WP-SKS-00304 66-WP-SKS 2016-09-17 00873263003190 WayPoint™ Implant Kit 66-WP-IKS-00319 66-WP-IKS 2016-09-17 00873263009604 microTargeting™ Measurement Probe 66-MO-31-00960 66-MO-31 2026-03-16 00873263009468 microTargeting™ Platform MP-KIT-P-VO-00946 MP-KIT-P-VO 2026-03-16 00873263009475 microTargeting™ Measurement Probe 66-MO-31-00960 66-MO-31 2026-03-16 10873263009625 microTargeting™ Electrode MTDWLN(BP)(BP11)-00962 MTDWLN(BP)(BP11) 2026-03-12 00873263009611 microTargeting™ Electrode MTDWLP(BP)(BP11)-00961 MTDWLP(BP)(BP11) 2026-03-12 10873263009618 microTargeting™ Electrode MTDWLP(BP)(BP11)-00961 MTDWLP(BP)(BP11) 2026-03-12 00873263009628 microTargeting™ Electrode MTDWLN(BP)(BP11)-00962 MTDWLN(BP)(BP11) 2026-03-12 00873263002254 STar™ Drive XL Frame Adapter 70-FA-RD-XL-00225 70-FA-RD-XL 2016-09-17 00873263002285 STar™ Drive XL Frame Adapter 70-FA-LX-XL-00228 70-FA-LX-XL 2016-09-17 00873263002322 STar™ Drive Frame Adapter 70-FA-LX-00232 70-FA-LX 2016-09-17 00873263002360 microTargeting™ STar™ Array Insertion Tube Extractor 70-CN-ET-00236 70-CN-ET 2016-09-17 00873263006047 WayPoint™ Entry Offset Mounting Hub 66-MP-EH-00604 66-MP-EH 2018-04-01 00873263006184 STar™ Drive Frame Adapter 70-FA-GP-00618 70-FA-GP 2017-08-29 00873263008546 STar™ Drive Frame Adapter 70-FA-LX-NN-00854 70-FA-LX-NN 2022-09-26 00873263009581 STar™ Drive Frame Adapter 70-FA-LS-00958 70-FA-LS 2026-01-25
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