Optical distance sensor ROSAS00316

GUDID 03760244032195

OPTICAL DISTANCE SENSOR (V3) instrument Rosa One 3.1 (brain application) Optical distance sensor for contactless location of anatomical structures or landmarks. Used for markerless automatic registration and free-hand navigation

MEDTECH

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• Primary Device ID: 03760244032195
• NIH Device Record Key: 2b3564c1-af87-477e-bab6-69593621b8e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optical distance sensor
• Version Model Number: 174007
• Catalog Number: ROSAS00316
• Company DUNS: 264502977
• Company Name: MEDTECH
• 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: false
• 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
GS1	03760244032195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200511

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-23
• Device Publish Date: 2021-06-15

On-Brand Devices [Optical distance sensor]

• 03760244031150: OPTICAL DISTANCE SENSOR (V3) instrument Rosa 3.0 Optical distance sensor for contactless locatio
• 03760244032195: OPTICAL DISTANCE SENSOR (V3) instrument Rosa One 3.1 (brain application) Optical distance sensor