RGK Octane Sub4 OCTANE-SUB4

GUDID 00016958059373

The Sub4 is an ultra lightweight and rigid wheelchair that is perfectly designed to fit you and your lifestyle. No corrosion - Titanium will not rust and is very resistant to corrosion and salt water. Perfect for adventures out and about.

SUNRISE MEDICAL (US) LLC

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• Primary Device ID: 00016958059373
• NIH Device Record Key: 5bd83fd5-55a7-46e9-9496-8b8df61850a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RGK Octane Sub4
• Version Model Number: Sub 4
• Catalog Number: OCTANE-SUB4
• Company DUNS: 962525056
• Company Name: SUNRISE MEDICAL (US) LLC
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016958059373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200135

FDA Product Code

• IOR: Wheelchair, Mechanical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-09-05

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