Identity
- Trade Name
- TSI/ERI Driver FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- 3.25mm TSI/ERI Driver (Short) Places 3.25mm TSI/ERI Implants FDA UDI
- Model / Reference
- 3.25mm TSI/ERI Driver (Short) FDA UDI
- Description
- 3.25mm TSI/ERI Driver (Short) Places 3.25mm TSI/ERI Implants FDA UDI
Identifiers
- Catalog Number
- 0014 FDA UDI
- Primary DI / UDI-DI
- D7850014S0 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
TSI/ERI Driver by Oco Biomedical — 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 |
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Manufacturer
- Manufacturer
- Oco Biomedical
Sources (1)
- FDA UDI e490112c-51b9-4787-9d31-b811ab0162d6 35 fields · synced Jun 1, 2026