Identity
- Trade Name
- Freedom Spinal Cord Stimulator System FDA UDI
- Generic Name
- Analgesic spinal cord electrical stimulation system FDA UDI
- Device Name
- Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel B US FDA UDI
- Model / Reference
- FR8A-TRL-B0 FDA UDI
- Description
- Freedom Spinal Cord Stimulator System Freedom-8A Trial Kit Channel B US FDA UDI
Identifiers
- Catalog Number
- S8T-1B US FDA UDI
- Primary DI / UDI-DI
- 00859619004929 FDA UDI
- 510(k) Number
- K150517 FDA UDI
- FDA Product Code
- GZB FDA UDI
- GMDN Term
- Analgesic spinal cord electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.25 Gram FDA UDILength — 45 Centimeter FDA UDIOuter Diameter — 1.35 Millimeter FDA UDI
Category: Analgesic spinal cord electrical stimulation system
Freedom Spinal Cord Stimulator System by Stimwave Technologies Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150517 also covers:
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
- Freedom Spinal Cord Stimulator System — STIMWAVE TECHNOLOGIES INCORPORATED
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
- Stimwave Technologies Incorporated
Sources (1)
- FDA UDI 23016776-9c4b-4a68-8a77-5ed313828be2 37 fields · synced May 30, 2026