DORO® Flexible Arm

GUDID 04250435502778

DORO® Flexible Arm 300 mm

pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung

Surgical retraction system, reusable

• Primary Device ID: 04250435502778
• NIH Device Record Key: 42721157-b837-402a-812c-4af8d931e6f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORO® Flexible Arm
• Version Model Number: 3114-35
• 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	04250435502778 [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

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

[04250435502778]

Moist Heat or Steam Sterilization

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® Flexible Arm]

• 04250435502778: DORO® Flexible Arm 300 mm
• 04250435502761: DORO® Flexible Arm 230 mm