Portable UV Sanitizer

GUDID 00850017524224

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

STRAIGHT SMILE LLC

Ultraviolet device microbial reduction unit
Primary Device ID00850017524224
NIH Device Record Keyb58ae7d8-6d35-4182-9c9e-18f5e5ff9cdf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortable UV Sanitizer
Version Model NumberBYTEUVS
Company DUNS081010579
Company NameSTRAIGHT SMILE LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017524224 [Primary]

FDA Product Code

NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-28
Device Publish Date2023-03-20

Devices Manufactured by STRAIGHT SMILE LLC

00850017524200 - Brightbyte Pro (wireless) Whitening Kit2023-09-15 [Wireless] LED teeth whitening kit
00850017524224 - Portable UV Sanitizer2023-03-28Portable ultraviolet sanitizer case intended to disinfect dental appliances (i.e. aligners, retainers, chewies, toothbrushes)
00850017524224 - Portable UV Sanitizer2023-03-28 Portable ultraviolet sanitizer case intended to disinfect dental appliances (i.e. aligners, retainers, chewies, toothbrushes)
00850017524064 - BrightByte2022-10-10 A liquid cleansing agent used to remove small debris from plastic aligners
00850017524088 - Brightbyte Pro Whitening Kit2022-06-14 LED teeth whitening kit
00850017524118 - Brightbyte Pro Refill Pens2022-06-14 Whitening and Desensitizing Gel Pens
00850017524002 - Smile Stretcher2022-06-10 Device to retract the lips/cheeks to facilitate viewing of the teeth.
00850017524019 - Impression Kit Standard2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit
00850017524033 - Impression Rekit (Small)2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit

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