| Primary Device ID | 00812537037158 |
| NIH Device Record Key | b395e9f4-41f2-4754-b2ed-c828da3eb4be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TD2 Thigh Wrap |
| Version Model Number | 34018 |
| Company DUNS | 067140761 |
| Company Name | NALU MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812537037158 [Primary] |
| GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 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) | 2026-03-06 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 | 2026-03-05The thigh wrap is an alternative to the adhesive clip for holding the therapy disc in place on the body. The Therapy Disc is inserted in the thigh wrap and positioned over the implant. |
| 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 |