FDA UDI
In Commercial Distribution
🇺🇸 United States
Sierra
DI: 00817650020094
·
Model: Sierra outdoor
·
Harmar Summit, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sierra
- Primary DI
- 00817650020094
- Version / Model
- Sierra outdoor
- Catalog Number
- IL500
- Company Name
- Harmar Summit, LLC
- Labeler DUNS
- 144008062
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-04-19
- Public Version Status
- Update
- Public Device Record Key
- 094c88b5-560d-40a5-a65c-41c7c1fc7758
Device Description
Incline stairway lift outdoor
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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PCE | Permanently mounted wheelchair platform lift | Physical Medicine | 890.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17817 | Stairlift, platform | A mains electricity (AC-powered) device designed with a platform typically used to accommodate a user sitting in their wheelchair to be transported up and down a staircase. This electromechanical device is typically attached to one or more rails which follow the shape and angle of the staircase, but may be affixed in another manner. It will typically be installed in public venues, institutions, and for home-use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817650020094 | GS1 |
Customer Contacts
- Phone
- +1(800)833-0478
- [email protected]