Nalu Medical, Inc. 12009-040-US

GUDID 00812537036236

Trial Lead (4 contact, 40 cm)

NALU MEDICAL, INC.

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system lead
Primary Device ID00812537036236
NIH Device Record Key8366daad-e097-4741-87c8-7f120e03a7e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNalu Medical, Inc.
Version Model Number12009-040-US
Catalog Number12009-040-US
Company DUNS067140761
Company NameNALU MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com
Phone1-800-618-3402
Emailinfo@nalumed.com

Device Dimensions

Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter
Length40 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100812537036236 [Primary]

FDA Product Code

GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-02
Device Publish Date2021-07-23

On-Brand Devices [Nalu Medical, Inc.]

00812537032313Lead Blank, 50 cm
00812537032672Limb Cuff, Large (Black)
00812537032634Limb Cuff (Black)
00812537032597Relief Belt (Black)
00812537032535Adhesive Test Patch Pack
00812537032511Adhesive Clip Pack (H300)
00812537032498Adhesive Clip Pack (H100)
00812537032474Adhesive Clip Pack (H200)
00812537035574Stylet (straight, 30 cm)
00812537032955Lead Kit (4 contact, 40 cm, Tined)
00812537032924Nalu Neurostimulation Kit (Integrated, Single 4, 40 cm, Tined)
00812537031057Lead Kit (4 contact, 25 cm, Tined)
00812537031040Lead Extension Kit (4)
00812537030999Nalu Neurostimulation Kit (Ported, Single 4)
00812537030982Nalu Neurostimulation Kit (Integrated, Single 4, 25 cm, Tined)
00812537030944Nalu Neurostimulation Kit (Integrated, Dual 8, 40 cm)
00812537031934Trial Lead (8 contact, 60 cm)
00812537035680Peripheral Nerve Stimulation Lead (8 contact, 60 cm)
00812537035666Peripheral Nerve Stimulation Lead (8 contact, 40 cm)
00812537035642Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
00812537035628Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
00812537035604Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
00812537033013SCS Remote App (compatible with iOS)
00812537032863Nalu Neurostimulation User's Kit
00812537032832Nalu User's Trial Kit
00812537032566Clinician Programmer
00812537032450EIC Extension
00812537032436EIC
00812537032290Stylet (straight, 65 cm)
00812537032276Stylet (Straight, 45 cm)
00812537032153Straw Tunneler
00812537032139IPG Insertion Tool
00812537032115Torque Wrench
00812537032092Pocket Tunneler
00812537032078Tearaway introducer assembly (14 cm sheath)
00812537032054Tearaway introducer assembly (10 cm sheath)
00812537032030Stylet (Bent, 65 cm)
00812537032016Stylet (Bent, 45 cm)
00812537031996Spoonbill Needle (6"/15 cm)
00812537031972Spoonbill Needle (4.5"/11 cm)
00812537031958Anchor
00812537031859Lead Extension (8 contact, 60 cm)
00812537031835Lead (8 contact, 60 cm)
00812537031811Lead (8 contact, 40 cm)
00812537031033Lead Extension Kit (8)
00812537031026Trial Lead Kit (8 contact, 60 cm)
00812537031019Lead Kit (8 contact, 60 cm)
00812537031002Lead Kit (8 contact, 40 cm)
00812537030975Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm)
00812537030968Nalu IPG Kit (Ported, Dual 8)
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