FDA UDI
In Commercial Distribution
🇺🇸 United States
Spectra WaveWriter™
DI: 08714729952046
·
Model: SC-5160
·
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Spectra WaveWriter™
- Primary DI
- 08714729952046
- Version / Model
- SC-5160
- Company Name
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Labeler DUNS
- 824951958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-05
- Public Version
- 4
- Public Version Date
- 2025-09-30
- Public Version Status
- Update
- Public Device Record Key
- 1590eaef-7be5-4c7f-b37e-17c3dcf09350
Device Description
External Trial Stimulator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | Unknown | 3 | |
| QRB | Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61472 | Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator | An electrically-powered, external component of a spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system intended to be used during a trial period (<= 30 days) to test operating parameters prior to implantation of the permanent system. It produces electrical impulses intended to relieve acute and/or chronic intractable pain (analgesia) via percutaneous electrodes (not included) placed in the epidural space of the spinal cord or in/near a peripheral nerve(s) (e.g., lumbar, truncal, in a limb). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729952046 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030017 | 271 |
| P030017 | 357 |
| P030017 | 363 |
| P030017 | 382 |