PN Wearable Accessory L/XL Horizontal

GUDID 00850051034185

PNS Wearable Accessory L/XL Horizontal

Curonix LLC

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID00850051034185
NIH Device Record Key38417024-469f-4341-bf7b-646ba6cb8b72
Commercial Distribution StatusIn Commercial Distribution
Brand NamePN Wearable Accessory L/XL Horizontal
Version Model Number00-52003
Company DUNS118972620
Company NameCuronix LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850051034185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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

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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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