DORO® Headrest System

GUDID 04250435534649

DORO® QR3 XTOM Headrest System

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp

• Primary Device ID: 04250435534649
• NIH Device Record Key: d9472dc0-4b3e-4693-8c1b-18b9fa4e2640
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Headrest System
• Version Model Number: 4002.100
• 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	04250435534649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191979

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: 2020-11-18

On-Brand Devices [DORO® Headrest System]

• 04250435509913: DORO® Intra-OP CT Headrest System consisting of 3006-20 3030-001 3034-00 3033-
• 04250435534649: DORO® QR3 XTOM Headrest System