Identity
- Trade Name
- Elite® Med-Twin Brackets FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Elite® Med-Twin .018 UR4/5 -7T 0A 0O FDA UDI
- Model / Reference
- 707-259-10 FDA UDI
- Description
- Elite® Med-Twin .018 UR4/5 -7T 0A 0O FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707085865 FDA UDI
- FDA Product Code
- EJF FDA UDI
- GMDN Term
- Orthodontic bracket, metal 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
Elite® Med-Twin Brackets by Ortho Organizers, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI eb2a9b84-b762-4e58-af09-3239df9ef34c 34 fields · synced Jun 9, 2026