FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 08714729121565
·
Model: SC-4395-50
·
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 08714729121565
- Version / Model
- SC-4395-50
- Company Name
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Labeler DUNS
- 824951958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-11-09
- Public Version
- 5
- Public Version Date
- 2026-01-19
- Public Version Status
- Update
- Public Device Record Key
- 20770551-fe09-4fa1-b4a0-0c1000cbb1e8
Device Description
Enhanced Steering Kit with Stylet Cap 50cm
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 64578 | Central nervous system electrical stimulation system lead stylet | A wire intended to be percutaneously inserted into the brain and/or epidural space to aid in the percutaneous placement of an implantable central nervous system (CNS) electrical stimulation system lead. It is manipulated proximally with the distal working end typically comprised of thin metal wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729121565 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030017 | 000 |
| P030017 | 357 |
| P030017 | 363 |
| P030017 | 382 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 50 cm Length |