Duns Number:795572718
Device Description: XCP-ORA® Owandy Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® Kodak 4 Biteblocks (1 Vert XCP-ORA® Owandy Kit. Contains: 1 XCP-ORA® Arm and Ring, XCP-DS® Kodak 4 Biteblocks (1 Vertical Anterior, 2 Vertical Biteblocks on Bitewings), 4 Bitewings (2 Horizontal, 2 Vertical), 50 Bulk Sensor Covers.
Catalog Number
-
Brand Name
RINN®
Version/Model Number
556171
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EGZ
Product Code Name
Holder, film, x-ray
Public Device Record Key
a4d0f7a1-3a30-428f-b64e-9dff8519517e
Public Version Date
October 21, 2020
Public Version Number
3
DI Record Publish Date
September 23, 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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19532 |