Primary Device ID | 00850051034178 |
NIH Device Record Key | 14336983-0087-43e3-9ffd-7450662b2971 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Freedom System Accessories |
Version Model Number | MD0495-A |
Company DUNS | 118972620 |
Company Name | Curonix LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850051034178 [Primary] |
GZF | Stimulator, Peripheral Nerve, Implanted (Pain Relief) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-17 |
Device Publish Date | 2023-04-07 |
00850051034550 | Transmitter Assembly (915MHz) |
00850051034543 | Torso Wearable S |
00850051034529 | Torso Wearable L |
00850051034512 | Torso Wearable XXL |
00850051034505 | Torso Wearable XL |
00850051034499 | Torso Wearable XS |
00850051034215 | FR Stylet |
00850051034208 | PNS Wearable Accessory S/M |
00850051034192 | PNS Wearable Accessory L/XL Vertical |
00850051034277 | Sterile Revision Kit |
00850051034260 | Antenna 27" Length |
00850051034253 | Antenna 12" Length |
00850051034178 | 6" Introducer |
00850051034161 | Guidewire 3-Pack |
00850051034154 | 13G Tuohy Needle 4.5" |
00850051034147 | 13G Tuohy Needle 6" |
00850051034888 | 8" Antenna w/ Snaps - Small |
00850051034864 | 42" Antenna w/ Velcro - Small |
00850051034840 | 18" Antenna w/ Velcro - Small |
00850051034826 | 12" Antenna w/ Velcro - Small |
00850051034819 | 8" Antenna w/ Velcro - Small |
00850051034796 | 42" Antenna w/ Snaps - Small |
00850051034772 | 18" Antenna w/ Snaps - Small |
00850051034758 | 12" Antenna w/ Snaps - Small |
00850051034741 | 40" Antenna w/ Velcro - Large |
00850051034710 | 28" Antenna w/Velcro - Large |
00850051034697 | 20" Antenna w/ Velcro - Large |
00850051034673 | 40" Antenna w/ Velcro - Large |
00850051034642 | 28" Antenna w/ Snaps - Large |
00850051034628 | 20" Antenna w/Snaps - Large |
00850051034604 | 13" Antenna w/Snaps - Large |
00850051034598 | 13" Antenna w/Velcro - Large |