FDA UDI
In Commercial Distribution
🇺🇸 United States
ProUltra PiezoFlow
DI: D716PIEZOFLOWAP1
·
Model: PIEZOFLOWAP
·
TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ProUltra PiezoFlow
- Primary DI
- D716PIEZOFLOWAP1
- Version / Model
- PIEZOFLOWAP
- Catalog Number
- PIEZOFLOWAP
- Company Name
- TULSA DENTAL PRODUCTS LLC
- Labeler DUNS
- 942778564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-18
- Public Version
- 1
- Public Version Date
- 2022-10-26
- Public Version Status
- New
- Public Device Record Key
- 919beb5a-c164-44cc-9158-5c81f62765cf
Device Description
ProUltra PiezoFlow Acc Pack
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELC | Scaler, ultrasonic | Dental | 872.4850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63814 | Root canal ultrasonic irrigation handpiece tip | A non-sterile, needle-like endpiece designed to be attached to an ultrasonic dental handpiece and intended to deliver irrigation solution to, and provide debridement of, the root canal by means of ultrasonic mechanical vibration, during an endodontic procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D716PIEZOFLOWAP1 | HIBCC |