FDA UDI
In Commercial Distribution
🇺🇸 United States
Portable UV Sanitizer
DI: 00850017524224
·
Model: BYTEUVS
·
STRAIGHT SMILE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Portable UV Sanitizer
- Primary DI
- 00850017524224
- Version / Model
- BYTEUVS
- Company Name
- STRAIGHT SMILE LLC
- Labeler DUNS
- 081010579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-20
- Public Version
- 1
- Public Version Date
- 2023-03-28
- Public Version Status
- New
- Public Device Record Key
- b58ae7d8-6d35-4182-9c9e-18f5e5ff9cdf
Device Description
Portable ultraviolet sanitizer case intended to disinfect dental appliances (i.e. aligners, retainers, chewies, toothbrushes)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| NOB | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850017524224 | GS1 |