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Gutta Percha Obturation Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref FiP0184Model Fi-P
Identity
- Trade Name
- Gutta Percha Obturation Device EUDAMEDDTE FDA UDI
- Generic Name
- Gutta-percha injector FDA UDI
- Device Name
- Gutta-percha injector FDA UDI
- Model / Reference
- Fi-P EUDAMEDFDA UDIFiP0184 EUDAMED
- Description
- Gutta-percha injector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843604671 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06944843604671 EUDAMED
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Gutta-percha injector FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gutta Percha Obturation Device by Guilin Woodpecker Medical Instrument Co., Ltd. — Class IIa — 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-06944843604671 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009139
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 8872e5f1-2113-4c08-ab6c-45037457cb95 61 fields · synced Oct 6, 2026
- FDA UDI dfd38e6b-96a5-4155-a6ef-d29f842966fb 33 fields · synced May 29, 2026