Duns Number:021443502
Device Description: PowerXL, Shrouded Power Table with Adjustable Backrest and Drop Section with casters
Catalog Number
-
Brand Name
Clinton Industries
Version/Model Number
81399-087
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
INQ
Product Code Name
Table, Powered
Public Device Record Key
b9e4545c-107a-446a-9469-6d6e79b73c38
Public Version Date
August 25, 2022
Public Version Number
1
DI Record Publish Date
August 17, 2022
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 | 288 |