FDA UDI
In Commercial Distribution
🇺🇸 United States
Precision™
DI: 08714729893301
·
Model: SC-9208-55E
·
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Precision™
- Primary DI
- 08714729893301
- Version / Model
- SC-9208-55E
- Company Name
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Labeler DUNS
- 824951958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-14
- Public Version
- 6
- Public Version Date
- 2025-12-17
- Public Version Status
- Update
- Public Device Record Key
- 76893314-cba6-4aaa-bc1b-a89b35c3e8ca
Device Description
S8 Trial Adapter, 55cm
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
- Yes
- 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 |
|---|---|---|---|---|
| 63365 | Implantable electrical stimulation system intraoperative test lead | A flexible wire intended to be used during open surgical implantation of an electrical stimulation system, and designed to conduct electrical impulses from an external (nonimplantable) pulse generator to the implantable electrode prior to full system implantation to ensure the electrode is positioned correctly, through intraoperative observation of the desired nerve response. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729893301 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030017 | 210 |
| P030017 | 314 |
| P030017 | 357 |
| P030017 | 363 |
| P030017 | 382 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 55 cm Length |