Duns Number:252468293
Device Description: Custom cut to length.The SuperPole is a high quality, commercial grade floor to ceiling sa Custom cut to length.The SuperPole is a high quality, commercial grade floor to ceiling safety pole. The SuperPole must be installed between a structural floor and ceiling by turning a jackscrew at the bottom of the pole. The pressure created by the jackscrew is strong enough for the SuperPole to support the user, yet it does not require drilling holes into the floor or ceiling. This is ideal for relocating or removing the pole. NOTE: The top plate has two holes that may be used to fix the plate directly to the ceiling joist if necessary. Do not install the pole where it is directly exposed to water.
Catalog Number
01596
Brand Name
SuperPole in Shipping Tube (cut less than 90 in.)
Version/Model Number
SP-P-CUT
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
5233b806-f4ac-400c-9cdb-d03ea4b50866
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 |