Identity
- Trade Name
- Stainless Steel Tube EUDAMEDGeneric Buccal Tubes FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- Stainless Steel Tube EUDAMEDWELD TUBE LR 1ST MOL 018/018AUX NON-CONV T=0 R=0 4.2MM W/HK FDA UDI
- Model / Reference
- 004-217CR EUDAMEDFDA UDI
- Description
- WELD TUBE LR 1ST MOL 018/018AUX NON-CONV T=0 R=0 4.2MM W/HK FDA UDI
Identifiers
- Catalog Number
- 004-217CR FDA UDI
- Primary DI / UDI-DI
- 00190746128936 EUDAMEDFDA UDI
- Basic UDI-DI
- 01907460000144DT EUDAMED
- FDA Product Code
- DZD FDA UDI
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
- GMDN Term
- Orthodontic tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Netherlands 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Orthodontic tube
Stainless Steel Tube by American Orthodontics — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 01907460000144DT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- American Orthodontics
- EUDAMED SRN
- US-MF-000007702
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED fdd0fe6d-f18f-41f6-aaab-db0c0633e880 61 fields · synced Jul 20, 2026
- FDA UDI 7c86208d-d74b-4387-b680-971efacb71f1 35 fields · synced May 30, 2026