FDA UDI
In Commercial Distribution
🇺🇸 United States
Vector Elite
DI: 00815962020276
·
Model: VEC-1100
·
BIONESS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vector Elite
- Primary DI
- 00815962020276
- Version / Model
- VEC-1100
- Company Name
- BIONESS INC.
- Labeler DUNS
- 182287727
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-07
- Public Version
- 3
- Public Version Date
- 2020-05-20
- Public Version Status
- Update
- Public Device Record Key
- 3fa686e7-319a-40e4-87eb-c6d2d4db2a26
Device Description
Vector Trolley Assembly, Elite Model
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| BXB | EXERCISER, POWERED | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58875 | Gait rehabilitation frame, electric | An electrically-powered, body-weight unloading, gait rehabilitation device designed to assist a patient with a walking/balance disability (neurogenic, muscular, or osseous in origin) regain lost motor function, by enabling them to hang in a dedicated harness in a vertical position and exercise (e.g., walk over the ground or moving surface of an elliptical/treadmill, climb stairs, perform sit-to-stand movements). It consists of a ceiling- or wall-mounted beam, or floor-standing frame with a motorized attachment assembly connected to the harness which supports the body weight. It is intended to be used in a clinical setting under professional supervision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815962020276 | GS1 |
Customer Contacts
- Phone
- +1(800)211-9136
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius