Primary Device ID | 10812537030187 |
NIH Device Record Key | eee2fc2e-44f3-4be2-8415-1d38e7e53495 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Nalu Medical, Inc. |
Version Model Number | 23007-US |
Catalog Number | 23007-US |
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 | 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 | |
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 |
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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 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 -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10812537030187 [Primary] |
GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-02-05 |
Device Publish Date | 2020-04-21 |
00812537032313 | Lead Blank, 50 cm |
00812537032672 | Limb Cuff, Large (Black) |
00812537032634 | Limb Cuff (Black) |
00812537032597 | Relief Belt (Black) |
00812537032535 | Adhesive Test Patch Pack |
00812537032511 | Adhesive Clip Pack (H300) |
00812537032498 | Adhesive Clip Pack (H100) |
00812537032474 | Adhesive Clip Pack (H200) |
00812537035574 | Stylet (straight, 30 cm) |
00812537032955 | Lead Kit (4 contact, 40 cm, Tined) |
00812537032924 | Nalu Neurostimulation Kit (Integrated, Single 4, 40 cm, Tined) |
00812537031057 | Lead Kit (4 contact, 25 cm, Tined) |
00812537031040 | Lead Extension Kit (4) |
00812537030999 | Nalu Neurostimulation Kit (Ported, Single 4) |
00812537030982 | Nalu Neurostimulation Kit (Integrated, Single 4, 25 cm, Tined) |
00812537030944 | Nalu Neurostimulation Kit (Integrated, Dual 8, 40 cm) |
00812537031934 | Trial Lead (8 contact, 60 cm) |
00812537035680 | Peripheral Nerve Stimulation Lead (8 contact, 60 cm) |
00812537035666 | Peripheral Nerve Stimulation Lead (8 contact, 40 cm) |
00812537035642 | Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm) |
00812537035628 | Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm) |
00812537035604 | Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm) |
00812537033013 | SCS Remote App (compatible with iOS) |
00812537032863 | Nalu Neurostimulation User's Kit |
00812537032832 | Nalu User's Trial Kit |
00812537032566 | Clinician Programmer |
00812537032450 | EIC Extension |
00812537032436 | EIC |
00812537032290 | Stylet (straight, 65 cm) |
00812537032276 | Stylet (Straight, 45 cm) |
00812537032153 | Straw Tunneler |
00812537032139 | IPG Insertion Tool |
00812537032115 | Torque Wrench |
00812537032092 | Pocket Tunneler |
00812537032078 | Tearaway introducer assembly (14 cm sheath) |
00812537032054 | Tearaway introducer assembly (10 cm sheath) |
00812537032030 | Stylet (Bent, 65 cm) |
00812537032016 | Stylet (Bent, 45 cm) |
00812537031996 | Spoonbill Needle (6"/15 cm) |
00812537031972 | Spoonbill Needle (4.5"/11 cm) |
00812537031958 | Anchor |
00812537031859 | Lead Extension (8 contact, 60 cm) |
00812537031835 | Lead (8 contact, 60 cm) |
00812537031811 | Lead (8 contact, 40 cm) |
00812537031033 | Lead Extension Kit (8) |
00812537031026 | Trial Lead Kit (8 contact, 60 cm) |
00812537031019 | Lead Kit (8 contact, 60 cm) |
00812537031002 | Lead Kit (8 contact, 40 cm) |
00812537030975 | Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm) |
00812537030968 | Nalu IPG Kit (Ported, Dual 8) |