FDA UDI
In Commercial Distribution
🇺🇸 United States
Nalu Medical, Inc.
DI: 00812537030630
·
Model: 12005-025
·
NALU MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Nalu Medical, Inc.
- Primary DI
- 00812537030630
- Version / Model
- 12005-025
- Catalog Number
- 12005-025
- Company Name
- NALU MEDICAL, INC.
- Labeler DUNS
- 067140761
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-10
- Public Version
- 2
- Public Version Date
- 2022-10-03
- Public Version Status
- Update
- Public Device Record Key
- 879713c9-b00d-4e3f-ad13-541efb3bcbc3
Device Description
Peripheral Nerve Stimulation Lead (4 contact, 25 cm, Tined)
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) | Neurology | 882.5870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62423 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection | An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812537030630 | GS1 | ||||
| Package | 10812537030637 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-618-3402
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 25 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 131 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry