Identity
- Trade Name
- GP2 ENDO SPREADER EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Manual endodontic filling material spreader FDA UDI
- Device Name
- Spreader EUDAMEDBurnishers, Spreaders EUDAMEDGP2 ENDO SPREADER FDA UDI
- Model / Reference
- AEEGP2S EUDAMEDFDA UDI
- Description
- GP2 ENDO SPREADER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841013104688 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013137678EKKD169678QW EUDAMED
- FDA Product Code
- EKH FDA UDI
- EMDN Code
- L159012 ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE EUDAMED
- GMDN Term
- Manual endodontic filling material spreader FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMEDIreland 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
EUDAMEDEUDAMED
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
Gp2 Endo Spreader 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 | 0841013137678EKKD169678QW | 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 (3)
- EUDAMED 99fc1e55-ed76-4a23-a21b-fc16b323bad3 61 fields · synced Jul 8, 2026
- FDA UDI e75a8832-b082-41d0-acf5-f82c2c0831dc 33 fields · synced May 30, 2026
- EUDAMED 9fedc1d0-83c8-4287-99b9-df96826b2438 61 fields · synced Jul 8, 2026