FDA UDI
In Commercial Distribution
🇺🇸 United States
The Orthodontic Store
DI: 00840326408230
·
Model: 60082
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Orthodontic Store
- Primary DI
- 00840326408230
- Version / Model
- 60082
- Catalog Number
- 60082
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 4791510f-fc25-414d-90e6-32730a1d568d
Device Description
TOOTHBRUSH SANITIZER LAMPS FOR USE WITH 60092 AND 60091
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 35150 | Ultraviolet ambient disinfection light | An electrically-powered light source designed to destroy bacteria and viruses in the air and/or on surfaces by emission of ultraviolet radiation into the surrounding environment. It is a mounted, or self-standing device, consisting of a tubular bulb or a unit containing the light source, and may include automatic motion sensors or timers, but does not include a user control unit or radiometers. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840326408230 | GS1 |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]