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Intraoral Elastic - Antimicrobial Black - Medium 5/16"
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.02.413Model LATEX ELASTICS
Identity
- Trade Name
- Intraoral Elastic - Antimicrobial Black - Medium 5/16" EUDAMEDMorelli FDA UDI
- Generic Name
- Orthodontic archwire/bracket ligature FDA UDI
- Device Name
- Intraoral Elastic - Antimicrobial Black - Medium 5/16" FDA UDI
- Model / Reference
- LATEX ELASTICS EUDAMED60.02.413 EUDAMEDFDA UDI
- Description
- Intraoral Elastic - Antimicrobial Black - Medium 5/16" FDA UDI
Identifiers
- Catalog Number
- 60.02.413 FDA UDI
- Primary DI / UDI-DI
- 07895742283858 EUDAMEDFDA UDI
- Basic UDI-DI
- 7895742178GP EUDAMEDB-07895742283858 EUDAMED
- FDA Product Code
- ECI FDA UDI
- EMDN Code
- Q010406 ORTHODONTIC LIGATURES EUDAMED
- GMDN Term
- Orthodontic archwire/bracket ligature FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
Intraoral Elastic - Antimicrobial Black - Medium 5/16" by Dental Morelli Ltda. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 7895742178GP | Class I | Active |
| EUDAMED | European Union | CE/MDR | 7895742178GP | 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 5aa73c42-ae49-4acd-89f2-e59e38f4ddb0 61 fields · synced Jul 28, 2026
- EUDAMED 05ee05d2-b369-4bb8-a812-e999b1eedd9d 61 fields · synced May 19, 2026
- FDA UDI 0a804494-96fd-44dc-aa05-0b3d0fb95f76 35 fields · synced May 30, 2026