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PerFect TCS Sterilizable Electrode Sheaths, 8 pcs
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S6010A
Identity
- Trade Name
- PerFect TCS Sterilizable Electrode Sheaths, 8 pcs EUDAMEDPerFect TCS FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- PerFect TCS II EUDAMED8 Sterilizable Electrode Sheaths FDA UDI
- Model / Reference
- S6010A EUDAMEDFDA UDI
- Description
- 8 Sterilizable Electrode Sheaths FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661S6010A1 EUDAMEDD661S6010A0 FDA UDI
- Basic UDI-DI
- B-D661S6010A1 EUDAMED
- 510(k) Number
- K071632 FDA UDI
- FDA Product Code
- EKZ FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4920 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
No
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
PerFect TCS Sterilizable Electrode Sheaths, 8 pcs by Coltene/Whaledent Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D661S6010A1 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 240a3e5e-198b-4ca5-9d99-13c986aed364 61 fields · synced Jul 31, 2026
- FDA UDI a2dc979c-2503-494f-b374-92d5831e61f6 35 fields · synced May 30, 2026