Identity
- Trade Name
- 3M™ FDA UDI
- Generic Name
- Orthodontic extraoral headgear FDA UDI
- Device Name
- Unitek(TM) Series 5 Facebow Short Size 2 .045 Diameter 15Degree-Occlusal Ea FDA UDI
- Model / Reference
- 4069-5113 FDA UDI
- Description
- Unitek(TM) Series 5 Facebow Short Size 2 .045 Diameter 15Degree-Occlusal Ea FDA UDI
Identifiers
- Catalog Number
- 328-224 FDA UDI
- Primary DI / UDI-DI
- 00652221070029 FDA UDI
- FDA Product Code
- DZB FDA UDI
- GMDN Term
- Orthodontic extraoral headgear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
3m™ by 3m Unitek Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- 3m Unitek Corporation
Sources (1)
- FDA UDI 4cd6ff6c-bfb5-4abc-aec5-fa569432e7f2 36 fields · synced Jun 8, 2026