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Hexagonal key for Gurin
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.02.011Model REUSABLE INSTRUMENTS
Identity
- Trade Name
- Hexagonal key for Gurin EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic elastomeric appliance pusher FDA UDI
- Device Name
- Hexagonal key for Gurin FDA UDI
- Model / Reference
- REUSABLE INSTRUMENTS EUDAMED75.02.011 EUDAMEDFDA UDI
- Description
- Hexagonal key for Gurin FDA UDI
Identifiers
- Catalog Number
- 75.02.011 FDA UDI
- Primary DI / UDI-DI
- 07895742019433 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07895742019433 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L150799 ORTHODONTIC INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthodontic elastomeric appliance pusher FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Portugal 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Hexagonal key for Gurin by Dental Morelli Ltda. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07895742019433 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dental Morelli Ltda.
- EUDAMED SRN
- BR-MF-000004812
- Authorised Representative
- Nuno Flores PT-AR-000003118
Sources (2)
- EUDAMED a677f872-883c-48ca-ab70-509da64c2ac8 61 fields · synced Jul 14, 2026
- FDA UDI 8516679b-d471-4411-ab5e-c13c0ab3df54 35 fields · synced May 30, 2026