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Boone Gauge - (4.0mm - 5.5mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 75.01.030Model REUSABLE INSTRUMENTS
Identity
- Trade Name
- Boone Gauge - (4.0mm - 5.5mm) EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic metal band pusher FDA UDI
- Device Name
- Boone Gauge - (4.0mm - 5.5mm) FDA UDI
- Model / Reference
- REUSABLE INSTRUMENTS EUDAMED75.01.030 EUDAMEDFDA UDI
- Description
- Boone Gauge - (4.0mm - 5.5mm) FDA UDI
Identifiers
- Catalog Number
- 75.01.030 FDA UDI
- Primary DI / UDI-DI
- 07895742083526 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742133FZ EUDAMEDB-07895742083526 EUDAMED
- FDA Product Code
- ECR FDA UDI
- EMDN Code
- L150704 ORTHODONTIC BAND PUSHERS, REUSABLE EUDAMED
- GMDN Term
- Orthodontic metal band 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
Boone Gauge - (4.0mm - 5.5mm) by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 7895742133FZ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742133FZ | 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 (3)
- EUDAMED b43994a1-34af-4118-89f0-b7fc6f0a756b 61 fields · synced Jul 12, 2026
- EUDAMED b2700762-e32a-48e7-83af-cd57fc2f2c4a 61 fields · synced May 18, 2026
- FDA UDI 94055f4f-deb2-4c28-94cd-d18c5937dd47 35 fields · synced May 30, 2026