SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel B

GUDID 00850051034048

SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel B

Curonix LLC

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
Primary Device ID00850051034048
NIH Device Record Key5754a3df-f4c6-4142-80c9-b1c3c7d48895
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel B
Version Model NumberFR4A-RCV-B0
Company DUNS118972620
Company NameCuronix LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
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
GS100850051034048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZBStimulator, Spinal-Cord, 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

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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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