DORO® Radiolucent Extension Bar

GUDID 04250435504048

DORO® Radiolucent Extension Bars 150 mm Set with Single Pin and Double Pin Arm 1x 4002-20-103 Arm 01

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp

• Primary Device ID: 04250435504048
• NIH Device Record Key: de19c9ee-c43c-46f3-94f4-3c41f387a3e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Radiolucent Extension Bar
• Version Model Number: 4002-15
• 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	04250435504048 [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: 2016-12-15

On-Brand Devices [DORO® Radiolucent Extension Bar]

• 04250435504048: DORO® Radiolucent Extension Bars 150 mm Set with Single Pin and Double Pin Arm 1x 4002-20-10
• 04250435504017: DORO® Radiolucent Extension Bars 185 mm, Set with Single Pin and Double Pin Arm
• 04250435503973: DORO® Radiolucent Extension Bars 120 mm, Set with Single Pin and Double Pin Arm