MEDTRONIC FHC MICRODRIVE HOLDER ROSAS00018

GUDID 03760244030108

MEDTRONIC FHC MICRODRIVE HOLDER (V2) instrument Rosa 3.0 mechanical holder for FHC DBS microdrive, supplied with M5 x 10 wing nut

MEDTECH

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 03760244030108
• NIH Device Record Key: 6e481043-aff7-499e-9b21-54a540345e39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDTRONIC FHC MICRODRIVE HOLDER
• Version Model Number: ROSA-282C
• Catalog Number: ROSAS00018
• 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	03760244030108 [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

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

[03760244030108]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-02
• Device Publish Date: 2016-10-09

On-Brand Devices [MEDTRONIC FHC MICRODRIVE HOLDER ]

• 03760244030115: MEDTRONIC FHC MICRODRIVE HOLDER (V3) instrument Rosa 3.0 instrument Rosa 3.1 mechanical holder f
• 03760244030108: MEDTRONIC FHC MICRODRIVE HOLDER (V2) instrument Rosa 3.0 mechanical holder for FHC DBS microdriv