FDA UDI
In Commercial Distribution
🇺🇸 United States
Johnson-Promident
DI: 00843471113431
·
Model: SCALER-BLIS-SW
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Johnson-Promident
- Primary DI
- 00843471113431
- Version / Model
- SCALER-BLIS-SW
- Catalog Number
- SCALER-BLIS-SW
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-23
- Public Version
- 1
- Public Version Date
- 2022-12-01
- Public Version Status
- New
- Public Device Record Key
- 9a4b34f4-fded-4d02-a288-c9346b74cc0c
Device Description
FLEXSONIC SWIVEL AIR SCALER W/UNIVERSAL TIP AND WRENCH
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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELC | Scaler, ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44907 | Ultrasonic dental scaling/debridement system handpiece | A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843471113438 | GS1 | INNER PACK | 1 | In Commercial Distribution | |
| Primary | 00843471113431 | GS1 |
Customer Contacts
- Phone
- +1 (800) 210-8945
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K011179 | 000 |