Duns Number:808251438
Device Description: Prone Stander
Catalog Number
-
Brand Name
Large Prone Stander
Version/Model Number
E950
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
KNL
Product Code Name
Board, Scooter, Prone
Public Device Record Key
31e73796-09ac-46c6-beeb-f3ff176fc92c
Public Version Date
September 26, 2022
Public Version Number
1
DI Record Publish Date
September 16, 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 | 49 |