Identity
- Trade Name
- TruForm FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- MN 1MOL BD KT STD NO/L R&L 176 FDA UDI
- Model / Reference
- K00560 FDA UDI
- Description
- MN 1MOL BD KT STD NO/L R&L 176 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885797100023 FDA UDI
- FDA Product Code
- ECM FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- 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
Category: Orthodontic bracket, metal
TruForm by Rmo — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Rmo
Sources (1)
- FDA UDI ea6f38c3-b1ea-4c94-8981-842dee78c95f 33 fields · synced Jun 6, 2026