DORO® Horseshoe RS

GUDID 04250435510469

DORO® Horseshoe RS Headrest RDL Pediatric, w/ Extension Bar

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest Neurosurgical headrest

• Primary Device ID: 04250435510469
• NIH Device Record Key: a48b8b95-e8c2-4a64-8045-3fbf1a99e3b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Horseshoe RS
• Version Model Number: 3035-70
• 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	04250435510469 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-16

On-Brand Devices [DORO® Horseshoe RS]

• 04250435529690: DORO® Horseshoe RS Headrest RDL Adult, w/ Extension Bar
• 04250435510551: DORO® Horseshoe RS Headrest RDL Adult, w/ Extension Bar
• 04250435510469: DORO® Horseshoe RS Headrest RDL Pediatric, w/ Extension Bar