Precision Pointer EM U1 029 01

GUDID B057U1029010

The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to navigate within the anatomic

Scopis GmbH

Electromagnetic surgical navigation device tracking system

• Primary Device ID: B057U1029010
• NIH Device Record Key: 2d992b0e-be1d-4b42-9ee2-bbead0d616c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Pointer EM
• Version Model Number: 1.0
• Catalog Number: U1 029 01
• 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: true
• Serial Number: false
• 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	B057U1029010 [Primary]

FDA Product Code

• PGW: Ear, Nose, And Throat Stereotaxic Instrument

Sterilization

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

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

[B057U1029010]

Moist Heat or Steam Sterilization

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: 2018-03-29The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to navigate within the anatomic
• 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