FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 08714729784456
·
Model: SC-4252
·
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
4
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 08714729784456
- Version / Model
- SC-4252
- 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
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 67d2c305-067b-4e16-a6c4-1bb2dd39af39
Device Description
28cm Straw Tunneling Tool
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 |
|---|---|---|---|---|
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor | Unknown | 3 | |
| PJS | Stimulator, electrical, implanted, for essential tremor | Unknown | 3 | |
| LGW | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | Unknown | 3 | |
| NHL | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37307 | Deep brain electrical stimulation system | An assembly of sterile implantable devices designed to apply electrical stimuli to specific areas of the deep brain for the treatment of movement disorders (e.g. essential tremor, symptoms of Parkinson’s disease, epilepsy, dystonia), psychiatric disorders (e.g. obsessive-compulsive disorder, depression, anxiety disorder), and/or to treat chronic, severe, intractable pain. It typically consists of leads implanted in the brain, lead extensions, and a pulse generator that is typically implanted near the sternum. | Yes | Active |
| 46801 | Subcutaneous tunneller, single-use | A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08714729784456 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030017 | 000 |
| P030017 | 270 |
| P150031 | 000 |
| P150031 | 028 |
| P150031 | 040 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 28 cm Length |