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Gracey Access 7-8 Xp (3/8) Green
EUDAMEDFDA UDIClass I (EU MDR)
Ref AEGA7-8XPXE
Identity
- Trade Name
- GRACEY ACCESS 7-8 XP (3/8) GREEN EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Periodontal Curette EUDAMEDGRACEY ACCESS 7-8 XP (3/8) GREEN FDA UDI
- Model / Reference
- AEGA7-8XPXE EUDAMEDFDA UDI
- Description
- GRACEY ACCESS 7-8 XP (3/8) GREEN FDA UDI
Identifiers
- Catalog Number
- AEGA7-8XPXE FDA UDI
- Primary DI / UDI-DI
- 00841013120121 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Gracey Access 7-8 Xp (3/8) Green 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 |
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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 de68d221-658d-4542-896f-8e4ce4ebc3d6 61 fields · synced Jun 19, 2026
- FDA UDI 1118a8cc-b0b3-452d-b8ad-707133d4f196 35 fields · synced May 30, 2026