Primary Device ID | 10810005340493 |
NIH Device Record Key | 63f94a6a-7679-4375-8ed7-d84a42e51582 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bulkamid |
Version Model Number | 60030 |
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 | 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 |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com | |
Phone | +1 (877) 929-6642 |
customersupport@axonics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10810005340493 [Primary] |
LNM | Agent, Bulking, Injectable For Gastro-Urology Use |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-07 |
Device Publish Date | 2023-08-30 |
10810005340578 - Axonics | 2024-08-06 PE & Torque Wrench |
10810005340479 - Axonics | 2023-09-18 Neurostimulator |
10810005340493 - Bulkamid | 2023-09-07Bulkamid 3mL |
10810005340493 - Bulkamid | 2023-09-07 Bulkamid 3mL |
10810005340486 - Axonics | 2022-06-22 Curved Stylet |
10810005340455 - Axonics | 2022-03-21 Neurostimulator |
10810005340424 - Axonics | 2021-04-21 Curved Charging Belt - Regular |
10810005340431 - Axonics | 2021-04-21 Curved Charging Belt - Extended |
10810005340127 - Axonics | 2020-04-06 PNE Lead |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BULKAMID 97797827 not registered Live/Pending |
AXONICS WOMEN'S HEALTH LIMITED 2023-02-16 |
BULKAMID 85410999 4315566 Live/Registered |
Contura A/S 2011-08-30 |
BULKAMID 79002593 2998438 Dead/Cancelled |
Contura A/S 2004-04-26 |