FDA UDI
In Commercial Distribution
🇺🇸 United States
Bionic Navigator™ 3D
DI: 00191506007546
·
Model: SC-7101-410
·
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bionic Navigator™ 3D
- Primary DI
- 00191506007546
- Version / Model
- SC-7101-410
- Company Name
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Labeler DUNS
- 824951958
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-15
- Public Version
- 2
- Public Version Date
- 2023-01-10
- Public Version Status
- Update
- Public Device Record Key
- 18a898a9-db1b-4197-91b7-ca74d5b1948d
Device Description
4.1 Installer
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60363 | Implantable electrical stimulation device management software | A software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191506007546 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030017 | 344 |