LEKSELL FRAME REGISTRATION PLATES ROSAS00347

GUDID 03760244031389

LEKSELL FRAME REGISTRATION PLATES instrument Rosa 3.0 instrument Rosa 3.1 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 Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244031389
• NIH Device Record Key: 0cf5d9d5-46de-4770-9d9a-71f1ffeb9d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEKSELL FRAME REGISTRATION PLATES
• Version Model Number: ROSA3-286A
• Catalog Number: ROSAS00347
• Company DUNS: 264502977
• Company Name: MEDTECH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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
GS1	03760244031389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151359

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

[03760244031389]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-06
• Device Publish Date: 2016-10-09

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