Identity
- Trade Name
- Stainless Steel Spring EUDAMEDSeparating Spring FDA UDI
- Generic Name
- Orthodontic spring FDA UDI
- Device Name
- Stainless Steel Spring EUDAMEDSPRING SELF-LOCKING SEPARATING 022 LONG 10/PKG FDA UDI
- Model / Reference
- 353-022C EUDAMEDFDA UDI
- Description
- SPRING SELF-LOCKING SEPARATING 022 LONG 10/PKG FDA UDI
Identifiers
- Catalog Number
- 353-022C FDA UDI
- Primary DI / UDI-DI
- 00190746056338 EUDAMEDFDA UDI
- Basic UDI-DI
- 01907460000223DQ EUDAMED
- FDA Product Code
- ECO FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
- GMDN Term
- Orthodontic spring 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
Yes
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 retainer
Stainless Steel Spring 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 | 01907460000223DQ | 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 ce80c7a1-8cae-450c-ac57-9d9b4f3a983d 61 fields · synced Jun 17, 2026
- FDA UDI 2e763c84-188b-47b9-a53b-486b1b47a600 35 fields · synced May 30, 2026