DORO® Extensionbar Horseshoe

GUDID 04250435501320

DORO® Extensionbar Horseshoe incl. Screw

Black Forest Medical GmbH

Neurosurgical headrest

• Primary Device ID: 04250435501320
• NIH Device Record Key: 5fa1010a-b429-4d7e-8cd3-250ec56ee407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Extensionbar Horseshoe
• Version Model Number: 3009-25
• Company DUNS: 313517922
• Company Name: Black Forest Medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	04250435501320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001808

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: 2025-12-12
• Device Publish Date: 2024-07-11