Identity
- Trade Name
- The Orthodontic Store FDA UDI
- Generic Name
- Orthodontic spring FDA UDI
- Device Name
- Niti Closed Coil Spring 12Mm Hvy FDA UDI
- Model / Reference
- ECCH12 FDA UDI
- Description
- Niti Closed Coil Spring 12Mm Hvy FDA UDI
Identifiers
- Catalog Number
- ECCH12 FDA UDI
- Primary DI / UDI-DI
- 00840326412329 FDA UDI
- FDA Product Code
- ECO FDA UDI
- GMDN Term
- Orthodontic spring FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
The Orthodontic Store by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI b6974ebc-19fd-4131-beb5-a4acf02e6f8b 36 fields · synced Jun 1, 2026