Duns Number:252468293
Device Description: The Uni-Fit Extender is a high quality, commercial grade installation accessory to be used The Uni-Fit Extender is a high quality, commercial grade installation accessory to be used with the SuperPole. The Uni-Fit Extender is intended to increase the floor to ceiling range of the SuperPole from 93-99" to 100-120" (236-251cm to 254-305cm). The Uni-Fit Extender is a metal tube that attaches between the top plate and the pole assembly of the SuperPole. The Uni-Fit Extender features a series of holes that can be selected depending on the desired floor to ceiling height range. The Uni-Fit Extender is only to be used with HealthCraft’s SuperPole System. The Uni-Fit Extender is not to be used with the SuperTrapeze, SuperPole Bariatric or SuperPole Ultra. The Uni-Fit Extender is not to be used in any other way than described.
Catalog Number
01922
Brand Name
Uni-Fit Extender™
Version/Model Number
SP-UF
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"
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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
15eaf43e-ddb8-48f1-a1ef-66cf18decf0d
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 |