PLANNING STATION-ROSA ONE- USA ROSAS00503

GUDID 03760244035127

planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244035127
• NIH Device Record Key: bce9d70a-d9bd-4e3e-b0ee-6077c2aa28f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLANNING STATION-ROSA ONE- USA
• Version Model Number: 164050
• Catalog Number: ROSAS00503
• 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	03760244035127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214065

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: 2022-06-28
• Device Publish Date: 2022-06-20

On-Brand Devices [PLANNING STATION-ROSA ONE- USA]

• 03760244035127: planning station DELL 3560 QUERTY power plug B for Rosa One 3.1.5
• 03760244034922: planning station DELL 3560 Querty power plug B for Rosa One 3.1.6