DORO LUCENT® iXI Headrest System

GUDID 04250435532126

DORO LUCENT® iXI Headrest System

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp

• Primary Device ID: 04250435532126
• NIH Device Record Key: 8f3f06c9-6007-4f9c-a63a-588e69fc4195
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO LUCENT® iXI Headrest System
• Version Model Number: 4003.500
• 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: 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	04250435532126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191740

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: 2
• Public Version Date: 2021-03-11
• Device Publish Date: 2020-11-19

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