FDA UDI
In Commercial Distribution
🇺🇸 United States
Complete Implant Surgical Kit
DI: D785COMPLETESURGKIT0
·
Model: Complete Surgical Kit
·
OCO BIOMEDICAL INC
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Complete Implant Surgical Kit
- Primary DI
- D785COMPLETESURGKIT0
- Version / Model
- Complete Surgical Kit
- Catalog Number
- Complete Surgical Kit
- Company Name
- OCO BIOMEDICAL INC
- Labeler DUNS
- 094146123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-21
- Public Version
- 3
- Public Version Date
- 2024-02-23
- Public Version Status
- Update
- Public Device Record Key
- ed90e749-f7cd-4479-aede-b021efc5c8c0
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIL | Gauge, Depth, Instrument, Dental | Dental | 872.4565 | 1 |
| EJL | Bur, Dental | Dental | 872.3240 | 1 |
| DZA | Drill, Dental, Intraoral | Dental | 872.4130 | 1 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45147 | Dental/maxillofacial surgical procedure kit, non-medicated, reusable | A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D785COMPLETESURGKIT0 | HIBCC |