Identity
- Trade Name
- APC™ II Unitek™ Gemini FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A Hk .018 5/Pk FDA UDI
- Model / Reference
- 3027-262 FDA UDI
- Description
- Unitek(TM) Gemini SL Bracket APC(TM) II Roth LL5 -22T/2A Hk .018 5/Pk FDA UDI
Identifiers
- Catalog Number
- 3027-262 FDA UDI
- Primary DI / UDI-DI
- 00652221226754 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic bracket, metal
APC™ II Unitek™ Gemini by 3m Unitek Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- 3m Unitek Corporation
Sources (1)
- FDA UDI 75e23aee-8fc6-444e-8a1b-e874fbde17bb 35 fields · synced May 30, 2026