Duns Number:427895198
Device Description: SteriStay is a mobile instrument table intended for use in the operating environment that SteriStay is a mobile instrument table intended for use in the operating environment that produces a directed, non-turbulent flow of air over sterile instruments and goods. The airflow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms.
Catalog Number
-
Brand Name
SteriStay
Version/Model Number
B2
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
a20980a0-9146-4f87-a06e-e582060ba293
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
September 05, 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 |