SmartByte Device

Primary DI: 00860001615326
Brand: SmartByte Device
Company: SCIENTIFIC INTAKE LIMITED CO.
Model: SI-001.01
Device description: Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake.
Published: 2019-05-23
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
Single use: true

Product Codes#

Code, Name table
Code	Name
ONY	Oral Removable Retainer For Weight Management

Code, Device, Specialty table
Code	Device	Specialty	Class
ONY	Oral Removable Retainer For Weight Management	Gastroenterology, Urology	2

Submission, Supplement table
Submission	Supplement
K171165	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K171165	000	SmartByte Device	Scientific Intake	2017-05-18	ONY

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860001615326	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860001615326	00860001615326	860001615326	0860001615326

Term, Definition table
Term	Definition
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.

Method table
Method

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00860001615319	SmartByte Palatal Impression Kit	SI-004.01		2019-05-23