DORO® Swivel Horseshoe

GUDID 04250435501214

DORO® Swivel Horseshoe Headrest Adult, w/ Extension Bar

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Neurosurgical headrest

• Primary Device ID: 04250435501214
• NIH Device Record Key: d9a9a9b1-de85-442a-904d-0762d72f7eda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Swivel Horseshoe
• Version Model Number: 3009-00
• 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: 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	04250435501214 [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: 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