Identity
- Trade Name
- Complete Implant Surgical Kit FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Complete Surgical Kit The OCO Biomedical Complete Implant Surgical System is organized with the OCO color-coded system that follows the implant placement procedures in an easy to follow, step-by-step format. Place SDI, 3.0, ISI, TSI, ERI, Macro™ and Engage™ OCO Biomedical implants. All components are labeled for easy removal and return to the tray after autoclaving for sterilization. FDA UDI
- Model / Reference
- Complete Surgical Kit FDA UDI
- Description
- Complete Surgical Kit The OCO Biomedical Complete Implant Surgical System is organized with the OCO color-coded system that follows the implant placement procedures in an easy to follow, step-by-step format. Place SDI, 3.0, ISI, TSI, ERI, Macro™ and Engage™ OCO Biomedical implants. All components are labeled for easy removal and return to the tray after autoclaving for sterilization. FDA UDI
Identifiers
- Catalog Number
- Complete Surgical Kit FDA UDI
- Primary DI / UDI-DI
- D785COMPLETESURGKIT0 FDA UDI
- FDA Product Code
- EIL FDA UDIEJL FDA UDIDZA FDA UDINDP FDA UDIDZN FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI872.3240 FDA UDI872.4130 FDA UDI872.3980 FDA UDI
- Commercial Distribution
- 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
Yes
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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Complete Implant Surgical Kit by Oco Biomedical — 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
- Oco Biomedical
Sources (1)
- FDA UDI ed90e749-f7cd-4479-aede-b021efc5c8c0 34 fields · synced May 30, 2026