LEKSELL FRAME REGISTRATION PLATES ROSAS00500

GUDID 03760244031914

LEKSELL FRAME REGISTRATION PLATES instrument Rosa One 3.1 (brain application) Leksell frame regsitration plates : calibrated tool for manual regsitration of the device with the leksell frame. Mounted on the leksell stereotactic frame.

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244031914
• NIH Device Record Key: 33b81eba-9231-483e-8d5a-e6b73b701730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEKSELL FRAME REGISTRATION PLATES
• Version Model Number: 174016-00
• Catalog Number: ROSAS00500
• 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	03760244031914 [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: 2020-10-28
• Device Publish Date: 2020-10-20

On-Brand Devices [LEKSELL FRAME REGISTRATION PLATES]

• 03760244031389: LEKSELL FRAME REGISTRATION PLATES instrument Rosa 3.0 instrument Rosa 3.1 Leksell frame regsitra
• 03760244034069: LEKSELL FRAME REGISTRATION PLATES instrument Rosa One 3.1 (brain application) Leksell frame regs
• 03760244031914: LEKSELL FRAME REGISTRATION PLATES instrument Rosa One 3.1 (brain application) Leksell frame regs