Duns Number:427895198
Device Description: Operio Mobile is a clean air zone unit, with an integrateddetachable instrument tray, to b Operio Mobile is a clean air zone unit, with an integrateddetachable instrument tray, to be used in the operatingzone, which produces a directed, non-turbulent ultracleanair flow to the surgical site during ophthalmic,orthopedic and neuro surgery and to the sterileinstruments used during surgery.
Catalog Number
-
Brand Name
Operio
Version/Model Number
Mobile
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ORC
Product Code Name
Air Filter Portable Apparatus
Public Device Record Key
074ac082-2f53-47ed-9f1d-23a928007f7c
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
April 08, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |