FDA UDI
In Commercial Distribution
🇺🇸 United States
PINNACLE LITE
DI: 00817650022982
·
Model: SL300
·
Harmar Summit, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PINNACLE LITE
- Primary DI
- 00817650022982
- Version / Model
- SL300
- Catalog Number
- SL300COS
- Company Name
- Harmar Summit, LLC
- Labeler DUNS
- 144008062
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-30
- Public Version
- 3
- Public Version Date
- 2023-04-19
- Public Version Status
- Update
- Public Device Record Key
- e41065cb-17a3-45df-a413-10a6be41a544
Device Description
PINNACLE LITE w/ Obstruction sensors
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 |
|---|---|---|---|---|
| PCD | Powered stairway chair lift | Physical Medicine | 890.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30038 | Stairlift, chair | A mains electricity (AC-powered) lifting device with an attached seating unit to accommodate a person with a disability, a geriatric or an infirm person to be transported up and down a staircase in a sitting position. 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 for home-use and in public venues and institutions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817650022982 | GS1 |
Customer Contacts
- Phone
- +1(800)833-0478
- [email protected]