Identity
- Trade Name
- ERGOPLANT EUDAMEDFDA UDI
- Generic Name
- Dental elevator, tooth/root FDA UDI
- Device Name
- Tunnelling instrument EUDAMEDERGOPLANT Tunneling Instrument, angled, 7 3/4", (195 mm), ERGOPLANT, non-sterile, reusable FDA UDI
- Model / Reference
- DX311R EUDAMEDFDA UDI
- Description
- ERGOPLANT Tunneling Instrument, angled, 7 3/4", (195 mm), ERGOPLANT, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- DX311R FDA UDI
- Primary DI / UDI-DI
- 04046963888558 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000013912J EUDAMED
- Direct Marketing DI
- 04046963888558 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental elevator, tooth/root FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
Yes
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
Yes
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
Ergoplant by Aesculap AG — 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 | 40392390000013912J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED dd84875d-5f95-4f55-860a-6d7776570c8e 61 fields · synced Jul 16, 2026
- FDA UDI 9c0b2f95-99f0-46af-b418-17af99ccb8ad 35 fields · synced May 30, 2026