FDA UDI
In Commercial Distribution
🇺🇸 United States
Symax
DI: 06970597720008
·
Model: Delite-S-160
·
SYMAX LIFT (CHINA) CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Symax
- Primary DI
- 06970597720008
- Version / Model
- Delite-S-160
- Company Name
- SYMAX LIFT (CHINA) CO., LTD.
- Labeler DUNS
- 421302871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-20
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c99ed6c6-88d9-4307-992b-b0e544e3421b
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| PCD | Powered Stairway Chair Lift | Physical Medicine | 890.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45888 | Stair-climbing wheelchair | A battery-powered, motor-driven, seat-support system on wheels designed to provide mobility to persons (not bariatric) restricted to a sitting position, and is intended to climb stairs by means of two endless belt tracks that are lowered from under the chair and adjusted to the angle of the stairs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970597720008 | GS1 |