DORO LUCENT® Base Unit

GUDID 04250435533710

DORO LUCENT® Base Unit, compact

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp

• Primary Device ID: 04250435533710
• NIH Device Record Key: 3f24353a-646e-4d3e-9225-367f0a04a57a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO LUCENT® Base Unit
• Version Model Number: 1101.022
• 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: 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	04250435533710 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-07

On-Brand Devices [DORO LUCENT® Base Unit ]

• 04250435533710: DORO LUCENT® Base Unit, compact
• 04250435520130: DORO LUCENT® Base Unit