FDA UDI
In Commercial Distribution
🇺🇸 United States
nvisia™ Corner Shelf (Oil Rubbed Bronze, 1Pk)
DI: 00689281033329
·
Model: INV-CS-ORB
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- nvisia™ Corner Shelf (Oil Rubbed Bronze, 1Pk)
- Primary DI
- 00689281033329
- Version / Model
- INV-CS-ORB
- Catalog Number
- 03332
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-30
- Public Version
- 1
- Public Version Date
- 2021-09-07
- Public Version Status
- New
- Public Device Record Key
- 5b9e55c2-7f10-41bd-8298-cb4c8e881a22
Device Description
The Invisia Corner Shelf is a combination grab bar and corner shelf, designed to disguise safety in a bathroom accessory. The Invisia Corner Shelf is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Corner Shelf is installed with appropriate fasteners to a structural wall. The tray (which holds bottles) is NOT intended to be a support product. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight
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 |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35584 | Bath hand rail | A bar intended to provide a supportive hand-hold for a person with a disability when raising or lowering themselves or changing their body position while bathing in a bath or bathing facility. It will typically be affixed to or around the bath. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10689281033326 | GS1 | CARTON | 3 | In Commercial Distribution | |
| Primary | 00689281033329 | GS1 |