DORO LUCENT® Headplate

GUDID 04250435532140

DORO LUCENT® Headplate

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Neurosurgical headrest

• Primary Device ID: 04250435532140
• NIH Device Record Key: aceb3348-91d2-4efb-b06d-bece264e98db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO LUCENT® Headplate
• Version Model Number: 4003.005
• 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	04250435532140 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-02
• Device Publish Date: 2018-10-02

On-Brand Devices [DORO LUCENT® Headplate]

• 04250435532140: DORO LUCENT® Headplate
• 04250435501344: DORO® Table Adapter