FDA UDI
In Commercial Distribution
🇺🇸 United States
Parts Box, SuperPole Ultra, SPHDU
DI: 00689281015578
·
Model: SP-BXU
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Parts Box, SuperPole Ultra, SPHDU
- Primary DI
- 00689281015578
- Version / Model
- SP-BXU
- Catalog Number
- 01557
- 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
- 274beb6e-f7fc-4d70-bc48-bbb239c22b1f
Device Description
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.
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 | 00689281015578 | GS1 |