AccessGUDID - DEVICE: SmartByte Device (00860001615326)

GUDID

Device Identifier (DI) Information

Brand Name: SmartByte Device
Version or Model: SI-001.01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SCIENTIFIC INTAKE LIMITED CO.

Primary DI Number: 00860001615326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 827444881 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONY	Oral Removable Retainer For Weight Management

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171165	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e6e6e2a-9b31-40be-840f-a9e0a9f6273d
Public Version Date: May 31, 2019
Public Version Number: 1
DI Record Publish Date: May 23, 2019