FDA UDI
In Commercial Distribution
🇺🇸 United States
Uni-Fit Extender™
DI: 00689281019224
·
Model: SP-UF
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Uni-Fit Extender™
- Primary DI
- 00689281019224
- Version / Model
- SP-UF
- Catalog Number
- 01922
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-25
- Public Version
- 1
- Public Version Date
- 2021-09-02
- Public Version Status
- New
- Public Device Record Key
- 15eaf43e-ddb8-48f1-a1ef-66cf18decf0d
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMR | Device, Transfer, Patient, Manual | General Hospital | 880.6785 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35586 | Hand rail | A device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00689281019224 | GS1 |