Hybrid Navigation Unit EM U2 040 04

GUDID B057U2040040

The Hybrid Navigation Unit EM is a high performance computer workstation with built-in electromagnetic Localization System. The workstation runs the n

Scopis GmbH

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: B057U2040040
• NIH Device Record Key: f701445a-ae24-43e9-a8f0-13c3bf37fa3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hybrid Navigation Unit EM
• Version Model Number: 2.2
• Catalog Number: U2 040 04
• Company DUNS: 341702266
• Company Name: Scopis GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B057U2040040 [Primary]

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-01-04

Devices Manufactured by Scopis GmbH

• B057U9020010 - Patient tracker tabs (PU 100): 2019-10-23 Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references pro
• B057U1017010 - Instrument clamp 2-6 mm: 2018-10-22 The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To
• B057U1017020 - Instrument clamp forceps: 2018-10-22 The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. T
• B057U1017030 - Instrument clamp 6-10 mm: 2018-10-22 The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. T
• B057U1017050 - Instrument clamp 10-16 mm: 2018-10-22 The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments.
• B057U4003260170 - NOVA AR: 2018-07-31 The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of ta
• B057U1029010 - Precision Pointer EM: 2018-03-29 The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to naviga
• B057U1029030 - Registration pointer EM-D: 2018-03-29 The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register th