Duns Number:094146123
Device Description: Complete Surgical KitThe OCO Biomedical Complete Implant Surgical System is organized with Complete Surgical KitThe OCO Biomedical Complete Implant Surgical System is organized with theOCO color-coded system that follows the implant placement procedures in aneasy to follow, step-by-step format. Place SDI, 3.0, ISI, TSI, ERI, Macro™ andEngage™ OCO Biomedical implants.All components are labeled for easy removal and return to the tray afterautoclaving for sterilization.
Catalog Number
Complete Surgical Kit
Brand Name
Complete Implant Surgical Kit
Version/Model Number
Complete Surgical Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIL
Product Code Name
Gauge, Depth, Instrument, Dental
Public Device Record Key
ed90e749-f7cd-4479-aede-b021efc5c8c0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 76 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |