DORO LUCENT® Headrest System

GUDID 04250435520420

DORO LUCENT® iMRI Headrest System MAQUET for PHILIPS Ingenia consisting of: 4003.311 4003.001 4003.011 1106.003

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp

• Primary Device ID: 04250435520420
• NIH Device Record Key: ffec5ef0-ced2-4a54-b73c-3ee447e3576b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO LUCENT® Headrest System
• Version Model Number: 4003.300
• 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	04250435520420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063494
• 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-15

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