DORO® Skull Clamp System

GUDID 04250435501863

DORO® Abbott Multi-Purpose Skull Clamp System, Pediatric consisting of: 3006-10 3020-01 3020-03 3020-50 3020-52 3020-55 3020-61 3020-62 3020-63

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Skull clamp

• Primary Device ID: 04250435501863
• NIH Device Record Key: ace12a6b-1191-43c5-9ed5-a19bb983c159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Skull Clamp System
• Version Model Number: 3021-00
• 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: true
• 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	04250435501863 [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® Skull Clamp System]

• 04250435501870: DORO® Universal Multi Purpose Skull Clamp System consisting of: 3006-00 3
• 04250435501863: DORO® Abbott Multi-Purpose Skull Clamp System, Pediatric consisting of: 3006-10 3020-01 3
• 04250435501573: DORO® Multi-Purpose Skull Clamp System, consisting of: 3006-10 3020-01 3020-03 3020-50 3020-55