Center Focus Handle B1-530-10

GUDID 20841736110564

Center Focus Handle with Intensity Control for Aurora II, Aurora 3, and Aurora Four Lights.

SKYTRON LLC

Operating room light system

• Primary Device ID: 20841736110564
• NIH Device Record Key: 67ef59fc-2461-493d-b1f1-6b98725805c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Center Focus Handle
• Version Model Number: Sterilizable Centere Focus Handle
• Catalog Number: B1-530-10
• Company DUNS: 078375583
• Company Name: SKYTRON LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	10841736110567 [Primary]
GS1	20841736110564 [Direct Marking]

FDA Product Code

• FTA: Light, Surgical, Accessories

Sterilization

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

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

[20841736110564]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-01-08
• Device Publish Date: 2017-03-23

On-Brand Devices [Center Focus Handle]

• 20841736110564: Center Focus Handle with Intensity Control for Aurora II, Aurora 3, and Aurora Four Lights.
• 20841736100275: Center Focus Handle with Intensity Control for Aurora II, Aurora 3 and Aurora Four Lights
• 10841736123185: Center Focus Handle with Intensity Control for Lumos Series
• 10841736124151: Center Focus Handle with Intensity Control for Lumos Series, black