DORO® Retractor System

GUDID 04250435506561

DORO® Quick-Clamp Halo Retractor System consisting of: 3117-00 3116-26 3116-25 3116-24 3116-23 3116-22 3116-21 3116-151 3116-141 3116-131 3116-121

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Surgical retractor/retraction system blade, reusable

• Primary Device ID: 04250435506561
• NIH Device Record Key: 1bcf92ab-bd27-44c0-bc41-642db6c3d2e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Retractor System
• Version Model Number: 1202.100T
• 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: true
• 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	04250435506561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001808

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

[04250435506561]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2016-12-15

On-Brand Devices [DORO® Retractor System]

• 04250435506561: DORO® Quick-Clamp Halo Retractor System consisting of: 3117-00 3116-26 3116-25 3116-24 3116
• 04250435502471: DORO® Halo Retractor System w/ C-Clamp consisting of: 3117-00 3116-26 3116-25 3116-24 3116