Nalu Medical 71003

GUDID 00812537037332

Nalu IPG Kit (Ported, Single 8)

NALU MEDICAL, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 00812537037332
• NIH Device Record Key: a74d6fd4-69af-4e71-adb0-8114f08ad6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nalu Medical
• Version Model Number: 71003
• Catalog Number: 71003
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812537037332 [Primary]

FDA Product Code

• GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-09
• Device Publish Date: 2024-05-01

Devices Manufactured by NALU MEDICAL, INC.

• 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: 2026-03-05 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