Identity
- Trade Name
- TruFit 2.0 FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- TruFit™2.0 .018 R UR6 NC OCBT HG-OCC -10T 8DO WLD (10PK) FDA UDI
- Model / Reference
- 490-11-1682 FDA UDI
- Description
- TruFit™2.0 .018 R UR6 NC OCBT HG-OCC -10T 8DO WLD (10PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190730033185 FDA UDI
- FDA Product Code
- DZD FDA UDI
- GMDN Term
- Orthodontic tube 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
TruFit 2.0 by Ortho Technology, 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
- Ortho Technology, Inc.
Sources (1)
- FDA UDI 4e9fc1f7-fd9f-46c2-bff6-efb632912fed 34 fields · synced Jun 6, 2026