Radiolucent Headholder Clamp - Doro 19147-06

GUDID 04056481004583

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481004583
• NIH Device Record Key: 63551c6a-2c00-4d89-9ce3-d81a9451c5f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiolucent Headholder Clamp - Doro
• Version Model Number: 19147-06
• Catalog Number: 19147-06
• Company DUNS: 314482980
• Company Name: Brainlab AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481004583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092467

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2016-09-15

Devices Manufactured by Brainlab AG

• 04056481145330 - CRANIAL 4PI HEADREST PLATFORM: 2025-07-04
• 04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD: 2025-07-04
• 04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.): 2025-07-04
• 04056481145361 - CRANIAL 4PI WEDGE 10 DEG.: 2025-07-04
• 04056481145378 - CRANIAL 4PI SPACER 20MM: 2025-07-04
• 04056481145453 - CRANIAL 4PI INDEXING PLATE: 2025-07-04
• 04056481145460 - CRANIAL 4PI HEAD SUPPORT WIDE: 2025-07-04
• 04056481145477 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (1 PC.): 2025-07-04