PNS Freedom-4A Permanent Neurostimulator Spare Kit Channel B

GUDID 00850051034345

PNS Freedom-4A Permanent Neurostimulator Spare Kit Channel B

Curonix LLC

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID00850051034345
NIH Device Record Key53bb86c7-26f5-43fd-a9fc-b63100052051
Commercial Distribution StatusIn Commercial Distribution
Brand NamePNS Freedom-4A Permanent Neurostimulator Spare Kit Channel B
Version Model NumberFR4A-SPR-B0
Company DUNS118972620
Company NameCuronix LLC
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 Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850051034345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-04-14
Device Publish Date2023-04-06

Devices Manufactured by Curonix LLC

00850051034598 - Freedom System Accessories2023-12-13 13" Antenna w/Velcro - Large
00850051034604 - Freedom System Accessories2023-12-13 13" Antenna w/Snaps - Large
00850051034628 - Freedom System Accessories2023-12-13 20" Antenna w/Snaps - Large
00850051034642 - Freedom System Accessories2023-12-13 28" Antenna w/ Snaps - Large
00850051034673 - Freedom System Accessories2023-12-13 40" Antenna w/ Velcro - Large
00850051034697 - Freedom System Accessories2023-12-13 20" Antenna w/ Velcro - Large
00850051034710 - Freedom System Accessories2023-12-13 28" Antenna w/Velcro - Large
00850051034741 - Freedom System Accessories2023-12-13 40" Antenna w/ Velcro - Large

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