Primary Device ID | 10810005340288 |
NIH Device Record Key | 0c2aa886-0af4-4543-971b-e864a40eb892 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Axonics |
Version Model Number | 9009 |
Catalog Number | 9009 |
Company DUNS | 079562449 |
Company Name | AXONICS MODULATION TECHNOLOGIES, INC. |
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 | false |
Serial Number | true |
Manufacturing Date | true |
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 |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10810005340288 [Primary] |
EZW | Stimulator, Electrical, Implantable, For Incontinence |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-01 |
Device Publish Date | 2019-09-23 |
10810005340387 | Charging Device |
10810005340370 | Charging Station |
10810005340325 | Basic Trial Cable |
10810005340301 | Dilator and Sheath |
10810005340288 | Percutaneous Extension |
10810005340271 | Charging Belt - Extended |
10810005340264 | Charging Belt - Regular |
10810005340257 | Tined Lead Test Stim. Cable |
10810005340240 | Needle Test Stim. Cable |
10810005340233 | Carrier |
10810005340226 | Torque Wrench |
10810005340219 | Stimulation Ground Cables |
10810005340196 | Foramen Needle - Long |
10810005340189 | Foramen Needle - Short |
10810005340158 | Tined Lead |
10810005340141 | Tined Lead Kit |
10810005340134 | PNE Lead Implant Kit |
10810005340127 | PNE Lead |
10810005340103 | Remote Control |
10810005340080 | Lead Implant Kit |
10810005340066 | Neurostimulator |
10810005340059 | Trial Stimulator |
10810005340035 | Clinician Programmer |
10810005340028 | Clinician Programmer |
10810005340011 | Charging System |
10810005340431 | Curved Charging Belt - Extended |
10810005340424 | Curved Charging Belt - Regular |
10810005340455 | Neurostimulator |
10810005340486 | Curved Stylet |
10810005340479 | Neurostimulator |
10810005340578 | PE & Torque Wrench |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AXONICS 97565339 not registered Live/Pending |
AXONICS, INC 2022-08-25 |
AXONICS 86309695 4893460 Live/Registered |
Axonics Modulation Technologies, Inc. 2014-06-13 |
AXONICS 77329931 3466754 Live/Registered |
Axonics, Inc. 2007-11-14 |
AXONICS 73505138 1340485 Dead/Cancelled |
AXONICS, INC. 1984-10-22 |