Duns Number:615789729
Device Description: ROI-C Implant Trial with Depth Stop 12mmX14mm H7mm
Catalog Number
SI-ROIC-0004
Brand Name
ROI-C
Version/Model Number
SI-ROIC-0004
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OVE
Product Code Name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Public Device Record Key
de48ae85-2f24-404a-98b6-7f63ad8b30a8
Public Version Date
March 10, 2022
Public Version Number
4
DI Record Publish Date
March 24, 2017
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 | 433 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2452 |
| 3 | A medical device with high risk that requires premarket approval | 61 |
| U | Unclassified | 40 |