| Primary Device ID | 00812537037707 |
| NIH Device Record Key | 34f6c7d2-e0a0-429a-89b5-88a5fde89811 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lead Kit (4-Contact, 40cm, Tined) |
| Version Model Number | 72007 |
| Company DUNS | 067140761 |
| Company Name | NALU MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com | |
| Phone | 1-800-618-3402 |
| info@nalumed.com |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812537037707 [Primary] |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-06 |
| Device Publish Date | 2026-02-26 |
| 00812537037431 - 25cm Straight Stylet | 2026-03-06 Stiff wire(s) with a straight tip that is inserted into the Lead to aid in steering and positioning. |
| 00812537037448 - 40cm Straight Stylet | 2026-03-06 Stiff wire(s) with a straight tip that is inserted into the Lead to aid in steering and positioning. |
| 00812537037462 - Extended Torque Wrench | 2026-03-06 A torque limited hex driver that is used to tighten the connector set screws and the Anchor. |
| 00812537037691 - Lead Kit (4 Contact, 25cm, Tined) | 2026-03-06 The stimulating portion of the neurostimulator that is inserted subcutaneously near the target nerve. The kit includes the Tined |
| 00812537037707 - Lead Kit (4-Contact, 40cm, Tined) | 2026-03-06The stimulating portion of the neurostimulator that is inserted subcutaneously near the target nerve. The kit includes one (1) Tined Lead, one (1) 13cm Introducer and one (1) straight Stylet. |
| 00812537037707 - Lead Kit (4-Contact, 40cm, Tined) | 2026-03-06 The stimulating portion of the neurostimulator that is inserted subcutaneously near the target nerve. The kit includes one (1) T |
| 00812537037141 - TD2 Limb Cuff | 2026-03-05 The limb cuff holds the Therapy Disc in place over the Implantable Pulse Generator location. |
| 00812537037158 - TD2 Thigh Wrap | 2026-03-05 The thigh wrap is an alternative to the adhesive clip for holding the therapy disc in place on the body. The Therapy Disc is ins |
| 00812537037165 - TD2 Relief Belt, Large | 2026-03-05 The relief belt is an alternative to the adhesive clip for holding the therapy disc in place on the body. The Therapy Disc is in |