Identity
- Trade Name
- 3M™ Unitek™ FDA UDI
- Generic Name
- Orthodontic archwire FDA UDI
- Device Name
- Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .016x.022 Trq Arch (20 Torque) 10/Pk FDA UDI
- Model / Reference
- 300-797 FDA UDI
- Description
- Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .016x.022 Trq Arch (20 Torque) 10/Pk FDA UDI
Identifiers
- Catalog Number
- 300-797 FDA UDI
- Primary DI / UDI-DI
- 00652221052872 FDA UDI
- FDA Product Code
- DZC FDA UDI
- GMDN Term
- Orthodontic archwire 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
No
FDA UDI
Category: Orthodontic archwire
3M™ Unitek™ by 3m Unitek Corporation — 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
- 3m Unitek Corporation
Sources (1)
- FDA UDI a9042fb7-6564-4888-84b5-5f63a94914ea 35 fields · synced May 30, 2026