Identity
- Trade Name
- EXCAVATOR 70-71 (3/8) SS EUDAMEDSwede Dental FDA UDI
- Generic Name
- Dental excavator, reusable FDA UDI
- Device Name
- Excavator EUDAMEDEXCAVATOR 70-71 (3/8) SS FDA UDI
- Model / Reference
- SIEXC70-71Z EUDAMEDFDA UDI
- Description
- EXCAVATOR 70-71 (3/8) SS FDA UDI
Identifiers
- Catalog Number
- SIEXC70-71Z FDA UDI
- Primary DI / UDI-DI
- 00841013117589 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
- Sweden 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
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
Moist Heat or Steam Sterilization FDA UDI
Excavator 70-71 (3/8) Ss 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 |
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Manufacturer
- Manufacturer
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED c7344344-d21c-4395-a21e-57b5a027243e 61 fields · synced Jun 18, 2026
- FDA UDI cb1119ed-bd2f-493a-af61-4cd24d63cff6 36 fields · synced May 30, 2026