Identity
- Trade Name
- Uni-Fit Extender™ FDA UDI
- Generic Name
- Hand rail FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SP-UF FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 01922 FDA UDI
- Primary DI / UDI-DI
- 00689281019224 FDA UDI
- FDA Product Code
- FMR FDA UDI
- GMDN Term
- Hand rail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6785 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hand rail
Uni-Fit Extender™ by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Healthcraft Products Inc.
Sources (1)
- FDA UDI 15eaf43e-ddb8-48f1-a1ef-66cf18decf0d 34 fields · synced May 30, 2026