Duns Number:252468293
Device Description: The SuperPole Ultra is a high quality, commercial grade floor to ceiling safety pole (inte The SuperPole Ultra is a high quality, commercial grade floor to ceiling safety pole (intended usage same as SuperPole). The SuperPole Ultra is intended for applications with floor to ceiling ranges from 121-140" / 3073-3556mm. The SuperPole Ultra is not to be used with the SuperBar, SuperTrapeze, Angled Ceiling Plate or Uni-Fit Extender. The SuperPole Ultra parts (pole, extension tube and top plate - labelled for convenience) should not be used with the components of any other floor to ceiling poles.
Catalog Number
01557
Brand Name
Parts Box, SuperPole Ultra, SPHDU
Version/Model Number
SP-BXU
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
FMR
Product Code Name
Device, Transfer, Patient, Manual
Public Device Record Key
274beb6e-f7fc-4d70-bc48-bbb239c22b1f
Public Version Date
September 02, 2021
Public Version Number
1
DI Record Publish Date
August 25, 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 | 298 |