DORO® Swivel Horseshoe

GUDID 04250435502310

DORO® Swivel Horseshoe 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: 04250435502310
• NIH Device Record Key: ab6860cf-cd7d-4668-a705-3dc486c3b84f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Swivel Horseshoe
• Version Model Number: 3035-00
• 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	04250435502310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063494

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: 2016-12-15

On-Brand Devices [DORO® Swivel Horseshoe]

• 04250435502334: DORO® Swivel Horseshoe Headrest RDL Adult, w/ Extension Bar
• 04250435502310: DORO® Swivel Horseshoe Headrest RDL Pediatric, w/ Extension Bar
• 04250435501252: DORO® Swivel Horseshoe Headrest Adult, w/o Extension Bar
• 04250435501214: DORO® Swivel Horseshoe Headrest Adult, w/ Extension Bar
• 04250435501184: DORO® Swivel Horseshoe Headrest Pediatric, w/o Extension Bar
• 04250435501160: DORO® Swivel Horseshoe Headrest Pediatric, w/ Extension Bar w. Ext. Bar