Identity
- Trade Name
- EXCAVATOR 64-65 EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Dental excavator, reusable FDA UDI
- Device Name
- Excavator EUDAMEDEXCAVATOR 64-65 FDA UDI
- Model / Reference
- AEEXC64-65 EUDAMEDFDA UDI
- Description
- EXCAVATOR 64-65 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841013105005 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013135811EMOD169682EL EUDAMED
- FDA Product Code
- EKC FDA UDI
- EMDN Code
- L159002 DENTAL EXCAVATORS, REUSABLE EUDAMED
- GMDN Term
- Dental excavator, reusable 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Excavator 64-65 by American Eagle Instruments — 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 | 0841013135811EMOD169682EL | 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
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED e1507825-d8c8-4904-ac70-40bcf696c74b 61 fields · synced Jul 9, 2026
- FDA UDI 789ac80a-1629-42d6-bfa9-4864f392f3c6 33 fields · synced May 29, 2026