Identity
- Trade Name
- Orthoquest FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Cutanium 27° Nat Dimp 16X22 Lo FDA UDI
- Model / Reference
- EDCUN14 FDA UDI
- Description
- Cutanium 27° Nat Dimp 16X22 Lo FDA UDI
Identifiers
- Catalog Number
- EDCUN14 FDA UDI
- Primary DI / UDI-DI
- 00840326410141 FDA UDI
- FDA Product Code
- DZC FDA UDI
- GMDN Term
- Orthodontic archwire 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Orthoquest 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 00efa129-0b05-4b87-a18c-a15a934304d2 36 fields · synced Jun 1, 2026