Identity
- Trade Name
- Sierra FDA UDI
- Generic Name
- Stairlift, platform FDA UDI
- Device Name
- Incline stairway lift outdoor FDA UDI
- Model / Reference
- Sierra outdoor FDA UDI
- Description
- Incline stairway lift outdoor FDA UDI
Identifiers
- Catalog Number
- IL500 FDA UDI
- Primary DI / UDI-DI
- 00817650020094 FDA UDI
- FDA Product Code
- PCE FDA UDI
- GMDN Term
- Stairlift, platform FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stairlift, platform
Sierra by Harmar Summit, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stairlift, platform.
- Stair-Lifts: Pegasus — Garaventa (Canada) , Ltd. · Class II
- Incline Platform Lift — Garaventa (Canada) , Ltd. · Class II
- Stair-Lifts — Garaventa (Canada) , Ltd. · Class II
- Stair-Lift — Garaventa (Canada) , Ltd. · Class II
- Sierra — Harmar Summit, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Harmar Summit, LLC
Sources (1)
- FDA UDI 094c88b5-560d-40a5-a65c-41c7c1fc7758 35 fields · synced Jun 8, 2026