← Back to catalogue
Mt Value Gracey Access 11-12 (3/8)
EUDAMEDFDA UDIClass I (EU MDR)
Ref MGA11-12X
Identity
- Trade Name
- MT VALUE GRACEY ACCESS 11-12 (3/8) EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Periodontal Curette EUDAMEDMT VALUE GRACEY ACCESS 11-12 (3/8) FDA UDI
- Model / Reference
- MGA11-12X EUDAMEDFDA UDI
- Description
- MT VALUE GRACEY ACCESS 11-12 (3/8) FDA UDI
Identifiers
- Catalog Number
- MGA11-12X FDA UDI
- Primary DI / UDI-DI
- 00841013115899 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013141660EMSA737883F3 EUDAMED
- FDA Product Code
- EMS FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Periodontal curette FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Ireland 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
Moist Heat or Steam Sterilization FDA UDI
Mt Value Gracey Access 11-12 (3/8) 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 | 0841013141660EMSA737883F3 | 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 ccb5691e-4d00-485a-a539-b28882c9bb03 61 fields · synced Jul 28, 2026
- FDA UDI 1dd64784-46c9-4ad7-95de-86602933aa79 35 fields · synced May 30, 2026