Identity
- Trade Name
- Ortho Specialties FDA UDI
- Generic Name
- Orthodontic tube FDA UDI
- Device Name
- Trumpeted Bondable Non-Convertible Buccal Tube, Single, Mbt, Extended, Upper Left, .022 FDA UDI
- Model / Reference
- 781-201 FDA UDI
- Description
- Trumpeted Bondable Non-Convertible Buccal Tube, Single, Mbt, Extended, Upper Left, .022 FDA UDI
Identifiers
- Catalog Number
- 781-201 FDA UDI
- Primary DI / UDI-DI
- 00843471162620 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ortho Specialties 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 d6b4e143-2fda-47f7-a082-41827b1c2527 36 fields · synced May 30, 2026