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

• 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