AccessGUDID - DEVICE: Portable UV Sanitizer (00850017524224)

GUDID

Device Identifier (DI) Information

Brand Name: Portable UV Sanitizer
Version or Model: BYTEUVS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: STRAIGHT SMILE LLC

Primary DI Number: 00850017524224
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081010579 *Terms of Use

Device Description: Portable ultraviolet sanitizer case intended to disinfect dental appliances (i.e. aligners, retainers, chewies, toothbrushes)

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
65824	Ultraviolet device microbial reduction unit	A portable electrically-powered device intended to reduce microbial and organic soil loads on the surface of noninvasive medical equipment, and other non-porous contact surfaces, using ultraviolet C (UVC) light; it is not intended for device disinfection. It includes UVC lights and controls and is intended to be placed in proximity to the devices to be decontaminated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: b58ae7d8-6d35-4182-9c9e-18f5e5ff9cdf
Public Version Date: January 31, 2025
Public Version Number: 2
DI Record Publish Date: March 20, 2023