FDA UDI
In Commercial Distribution
🇺🇸 United States
Freedom Spinal Cord Stimulator System
DI: 00859619004035
·
Model: LBRD-915-2K
·
STIMWAVE TECHNOLOGIES INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Freedom Spinal Cord Stimulator System
- Primary DI
- 00859619004035
- Version / Model
- LBRD-915-2K
- Catalog Number
- LBRD-915-2K
- Company Name
- STIMWAVE TECHNOLOGIES INCORPORATED
- Labeler DUNS
- 078294927
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1a43b5a1-33c2-4c6f-9f10-9275286e4e8d
Device Description
Freedom Spinal Cord Stimulator System Longboard Wearable Antenna Assembly 915
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Neurology | 882.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61588 | Implantable spinal cord electrical stimulation system programmer | A battery-powered external device designed to change, telemetrically, one or more of the operating parameters (the programs) of an implanted spinal cord electrical stimulation system pulse generator (EPG). It includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver. It will typically also provide historic and/or current information regarding the performance of the implant. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859619004035 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150517 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 140 Degrees Fahrenheit