Duns Number:003032752
Device Description: Anesthesia Cart
Catalog Number
SXRXSANES2
Brand Name
Starsys®
Version/Model Number
SXRXSANES2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 08, 2021
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BRY
Product Code Name
CABINET, TABLE AND TRAY, ANESTHESIA
Public Device Record Key
d22e29f4-2da1-497d-be76-9fb431b66998
Public Version Date
June 09, 2021
Public Version Number
2
DI Record Publish Date
April 23, 2021
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 | 9 |