Identity
- Trade Name
- TurboVUE™ EUDAMEDFDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Device Name
- Handpiece Sheath EUDAMEDSheath for TurboVue™ Handpiece D570 FDA UDI
- Model / Reference
- D572 EUDAMEDFDA UDI
- Description
- Sheath for TurboVue™ Handpiece D570 FDA UDI
Identifiers
- Catalog Number
- D572 FDA UDI
- Primary DI / UDI-DI
- 00810000520848 EUDAMEDFDA UDI
- Basic UDI-DI
- 081000052SHEATHR5 EUDAMED
- Direct Marketing DI
- 00810000520848 EUDAMED
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- Z12119001 TARTAR ABLATORS EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
TurboVUE™ by Parkell, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081000052SHEATHR5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Parkell Inc.
- EUDAMED SRN
- US-MF-000003761
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (2)
- EUDAMED 17392576-10fa-4720-8d6e-72a7d5ed5a1b 61 fields · synced Jul 13, 2026
- FDA UDI 3ebe2e7e-c702-455e-b294-bc3e60db65d2 36 fields · synced May 29, 2026