SmartByte Device

Basic Information

• Brand Name: SmartByte Device
• Primary DI: 00860001615326
• Version / Model: SI-001.01
• Company Name: SCIENTIFIC INTAKE LIMITED CO.
• Labeler DUNS: 827444881
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-23
• Public Version: 1
• Public Version Date: 2019-05-31
• Public Version Status: New
• Public Device Record Key: 6e6e6e2a-9b31-40be-840f-a9e0a9f6273d

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ONY	Oral Removable Retainer For Weight Management	Gastroenterology, Urology	876.5981	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48184	Oral intake restriction kit	A collection of devices intended to help reduce oral caloric intake for a patient undergoing a weight loss program. It includes a custom-made oral intake restrictor with integrated microsensor designed to reduce the oral capacity for food and to measure/record the usage of the device to provide data to enable the patient or their healthcare provider monitor progress on-line, and a microsensor reader. This kit is intended for single-patient use only (i.e., the patient from whom the palate impression was taken for the customization of the oral intake restrictor) and contains reusable devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001615326	GS1

Premarket Submissions

Submission Number	Supplement Number
K171165	000