DORO LUCENT® iMRI Pad

GUDID 04250435516294

DORO LUCENT® iMRI Pad Trumpf

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Neurosurgical headrest

• Primary Device ID: 04250435516294
• NIH Device Record Key: b9851d45-f65f-432b-b2ef-38a3ffe4bfb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO LUCENT® iMRI Pad
• Version Model Number: 4003.212
• Company DUNS: 313517922
• Company Name: pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
• 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: true
• Serial Number: false
• 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	04250435516294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032331

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-06-06

Devices Manufactured by pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

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• 04250435528129 - DORO® Lubricant HP500: 2023-08-03 DORO® Lubricant HP500, Six-pack
• 04250435537503 - DORO LUCENT® iMRI Transfer Collision Indicator: 2021-06-07 DORO LUCENT® iMRI Transfer Collision Indicator 700 MAQUET Alphamaquet, EU to GE
• 04250435502297 - DORO® Torque Screwdriver: 2021-04-14 DORO® Torque Screwdriver