DORO® Retractor System Radiolucent

GUDID 04250435502372

DORO® Quick-Clamp Halo Retractor System consisting of: 3110-80 3116-151 3116-141 3116-131 3116-121 3116-111 3110-85 3114-39 3037-55 3037-08-002 30

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Surgical retraction system, reusable

• Primary Device ID: 04250435502372
• NIH Device Record Key: 5c12a662-5c8c-4637-8be1-9f2ce1765e4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Retractor System Radiolucent
• Version Model Number: 3037-00
• 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: 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	04250435502372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032331

FDA Product Code

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

Sterilization

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

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

Moist Heat or Steam Sterilization

[04250435502372]

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

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