FDA UDI
In Commercial Distribution
🇺🇸 United States
Young PerioDT
DI: 00840326420362
·
Model: 100279
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Young PerioDT
- Primary DI
- 00840326420362
- Version / Model
- 100279
- Catalog Number
- 100279
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-05
- Public Version
- 1
- Public Version Date
- 2023-10-13
- Public Version Status
- New
- Public Device Record Key
- 4f665722-8ae7-469a-8c44-2302c502668c
Device Description
Young PerioDT Liquid Biofilm Debridement Sulfonated Phenolics, 1mL, 2pk
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| KJJ | CLEANSER, ROOT CANAL | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42345 | Dental mouthwash | A substance intended to be used to clean and disinfect the oral cavity (including teeth and gums) for personal hygiene and/or dental clinical procedures. It is available in various forms (e.g., liquid solution, dissolving tablets) which inhibit bacterial growth and sometimes provide specific benefits for teeth (e.g., fluoride, whitening agents). It is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00840326420379 | GS1 | Inner Pack | 2 | In Commercial Distribution | |
| Primary | 00840326420362 | GS1 |
Customer Contacts
- Phone
- +1 (800) 558-6684
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201785 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit