DORO LUCENT® Headrest System

GUDID 04250435535769

DORO LUCENT® iMRI Headrest System MIZUHO consisting of: 4003.311 4003.001 4003.011 4003.005 1106.003

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: 04250435535769
• NIH Device Record Key: 14d7fa80-e7d2-4260-bcee-d85fce0a0a7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO LUCENT® Headrest System
• Version Model Number: 4003.350
• 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 Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	04250435535769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063494

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: 2020-02-21

On-Brand Devices [DORO LUCENT® Headrest System]

• 04250435521984: DORO LUCENT® Headrest System Spine, Radiolucent consisting of 1101.021 1101.031 3033-00 3034
• 04250435521977: DORO LUCENT® Headrest System, Radiolucent consisting of 1101.021 1101.031 3033-00 3034-00 110
• 04250435520901: DORO LUCENT® iMRI Headrest System MAQUET for GE consisting of: 4003.311 4003.001 4003.011 1
• 04250435520420: DORO LUCENT® iMRI Headrest System MAQUET for PHILIPS Ingenia consisting of: 4003.311 4003.0
• 04250435516270: DORO LUCENT® Headrest System TRUMPF for SIEMENS Aera/Skyra MRI Systems consisting of: 4003.
• 04250435516249: DORO LUCENT® Headrest System MAQUET for SIEMENS Aera/Skyra MRI Systems consisting of: 4003.111
• 04250435535769: DORO LUCENT® iMRI Headrest System MIZUHO consisting of: 4003.311 4003.001 4003.011 4003.005 110