FDA UDI
In Commercial Distribution
🇺🇸 United States
Nevro®
DI: 00813426020879
·
Model: MADP2008-25B
·
NEVRO CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nevro®
- Primary DI
- 00813426020879
- Version / Model
- MADP2008-25B
- Company Name
- NEVRO CORP.
- Labeler DUNS
- 926599155
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-28
- Public Version
- 2
- Public Version Date
- 2026-04-13
- Public Version Status
- Update
- Public Device Record Key
- 684c41fd-a2ed-47ea-a03a-9b48b206b227
Device Description
Blue M8 Lead Adaptor Kit, 25cm Downsized
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48054 | Neural-tissue electrical stimulation lead adaptor | An implantable device intended to provide a functional and modified connection between existing neurostimulation leads/lead extensions and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation, the surgeon uses a tool to tighten the connections (e.g., a Hex wrench) and a medical adhesive to seal the connections from body fluid contamination. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813426020879 | GS1 |
Customer Contacts
- Phone
- 6502510005
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130022 | 025 |