| Primary Device ID | 00850051034277 |
| NIH Device Record Key | 39543fb6-ce98-4033-ae20-6160c99235cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Freedom System Accessories |
| Version Model Number | AF8A-ALL-1K |
| 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 | 00850051034277 [Primary] |
| GZB | Stimulator, Spinal-Cord, 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 |