NOVA AR U4 003

GUDID B057U4003260170

The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of target structures for su

Scopis GmbH

Stereotactic system application software

• Primary Device ID: B057U4003260170
• NIH Device Record Key: dcdce0aa-bd7f-44e0-bda5-ab7f703e4312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA AR
• Version Model Number: 2.6.17
• Catalog Number: U4 003
• 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	B057U4003260170 [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: 2018-07-31
• Device Publish Date: 2018-04-20

On-Brand Devices [NOVA AR]

• B057U4003260170: The Navigation Software NOVA AR provides import of image sets, building the image-based model of
• B057U4003260160: The Navigation Software NOCA AR provides import of image sets, building the image-based model of
• B057U40030: The Navigation Software NOVA AR provides import of image sets, building the image-based model of