FDA.reportPublic FDA data

PNS Freedom-8A Trial Neurostimulator Kit Channel A

Primary DI
00850051034376
Brand
PNS Freedom-8A Trial Neurostimulator Kit Channel A
Company
Curonix LLC
Model
FR8A-TRL-A0
Device description
PNS Freedom-8A Trial Neurostimulator Kit Channel A
Published
2023-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152178000StimQ Peripheral Nerve Stimulator (PNS) SystemStimq, LLC2016-03-11GZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051034376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051034376008500510343768500510343760850051034376

GMDN Terms#

Term, Definition table
TermDefinition
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantableAn electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118972620
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051034598Freedom System Accessories00-891132023-12-05
00850051034604Freedom System Accessories00-890132023-12-05
00850051034628Freedom System Accessories00-890202023-12-05
00850051034642Freedom System Accessories00-890282023-12-05
00850051034673Freedom System Accessories00-890402023-12-05
00850051034697Freedom System Accessories00-891202023-12-05
00850051034710Freedom System Accessories00-891282023-12-05
00850051034741Freedom System Accessories00-891402023-12-05
00850051034758Freedom System Accessories00-892122023-12-05
00850051034772Freedom System Accessories00-892182023-12-05
00850051034796Freedom System Accessories00-892422023-12-05
00850051034819Freedom System Accessories00-893082023-12-05
00850051034826Freedom System Accessories00-893122023-12-05
00850051034840Freedom System Accessories00-893182023-12-05
00850051034864Freedom System Accessories00-893422023-12-05
00850051034888Freedom System Accessories00-892082023-12-05
00850051034581SandShark Injectable Anchor SystemSHRK-ALL-1K-US2023-05-04
00850051034147Freedom System AccessoriesMD0532-A2023-04-07
00850051034154Freedom System AccessoriesMD0505-A2023-04-07
00850051034161Freedom System AccessoriesMD0630-A2023-04-07

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Primary DI, Brand, Company table
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0081253703743125cm Straight StyletNALU MEDICAL, INC.GZF2026-02-26
0081253703744840cm Straight StyletNALU MEDICAL, INC.GZF2026-02-26
00812537037462Extended Torque WrenchNALU MEDICAL, INC.GZF2026-02-26
00812537037691Lead Kit (4 Contact, 25cm, Tined)NALU MEDICAL, INC.GZF2026-02-26
00812537037707Lead Kit (4-Contact, 40cm, Tined)NALU MEDICAL, INC.GZF2026-02-26
00812537037141TD2 Limb CuffNALU MEDICAL, INC.GZF2026-02-25
00812537037158TD2 Thigh WrapNALU MEDICAL, INC.GZF2026-02-25
00812537037165TD2 Relief Belt, LargeNALU MEDICAL, INC.GZF2026-02-25
00812537037172TD2 Relief Belt, SmallNALU MEDICAL, INC.GZF2026-02-25
00812537037257Charger KitNALU MEDICAL, INC.GZF2026-02-25
00812537036984Base Station ChargerNALU MEDICAL, INC.GZF2026-02-24
00812537037127TD2 Patient KitNALU MEDICAL, INC.GZF2026-02-20
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537035802Therapy Disc, Reduced WarrantyNALU MEDICAL, INC.GZF2026-01-19
00812537037134TD2 Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537037660Nalu Medical, Inc.NALU MEDICAL, INC.GZF2025-12-08
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00816986020570StimTrial Patient KitBIOVENTUS LLCGZF2025-09-01
00816986020587StimTrial Stimulator KitBIOVENTUS LLCGZF2025-09-01
00816986020617Bioventus User KitBIOVENTUS LLCGZF2025-09-01
00816986020624Bioventus Clinician KitBIOVENTUS LLCGZF2025-09-01
00812537037189Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037196Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
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00812537037219Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037226Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01
00812537037233Nalu Medical, Inc.NALU MEDICAL, INC.GZF2024-05-01