SmartByte Device

GUDID 00860001615326

Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.

SCIENTIFIC INTAKE LIMITED CO.

Oral intake restriction kit

• Primary Device ID: 00860001615326
• NIH Device Record Key: 6e6e6e2a-9b31-40be-840f-a9e0a9f6273d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartByte Device
• Version Model Number: SI-001.01
• Company DUNS: 827444881
• Company Name: SCIENTIFIC INTAKE LIMITED CO.
• 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: true
• 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	00860001615326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171165

FDA Product Code

• ONY: Oral Removable Retainer For Weight Management

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: 2019-05-31
• Device Publish Date: 2019-05-23

Devices Manufactured by SCIENTIFIC INTAKE LIMITED CO.

• 00860001615319 - SmartByte Palatal Impression Kit: 2019-05-31 Single-use impression kit for taking VPS impression of patient's palate and upper and lower arches including all upper and lower
• 00860001615326 - SmartByte Device: 2019-05-31Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.
• 00860001615326 - SmartByte Device: 2019-05-31 Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.