Identity
- Trade Name
- The Orthodontic Store FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- O.P.C™ Midi Bracket, Mbt, Lower Right 1St Bicuspid W/Hook, .022 FDA UDI
- Model / Reference
- 605-224 FDA UDI
- Description
- O.P.C™ Midi Bracket, Mbt, Lower Right 1St Bicuspid W/Hook, .022 FDA UDI
Identifiers
- Catalog Number
- 605-224 FDA UDI
- Primary DI / UDI-DI
- 00843471161135 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
The Orthodontic Store 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Young Innovations, Inc.
Sources (1)
- FDA UDI e1fc3e03-e6fb-4cb8-bfba-23c02fa18354 36 fields · synced May 31, 2026