Bulkamid

GUDID 10810005340493

Bulkamid 3mL

AXONICS MODULATION TECHNOLOGIES, INC.

Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
Primary Device ID10810005340493
NIH Device Record Key63f94a6a-7679-4375-8ed7-d84a42e51582
Commercial Distribution StatusIn Commercial Distribution
Brand NameBulkamid
Version Model Number60030
Company DUNS079562449
Company NameAXONICS MODULATION TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com
Phone+1 (877) 929-6642
Emailcustomersupport@axonics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110810005340493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNMAgent, Bulking, Injectable For Gastro-Urology Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

Devices Manufactured by AXONICS MODULATION TECHNOLOGIES, INC.

10810005340578 - Axonics2024-08-06 PE & Torque Wrench
10810005340479 - Axonics2023-09-18 Neurostimulator
10810005340493 - Bulkamid2023-09-07Bulkamid 3mL
10810005340493 - Bulkamid2023-09-07 Bulkamid 3mL
10810005340486 - Axonics2022-06-22 Curved Stylet
10810005340455 - Axonics2022-03-21 Neurostimulator
10810005340424 - Axonics2021-04-21 Curved Charging Belt - Regular
10810005340431 - Axonics2021-04-21 Curved Charging Belt - Extended
10810005340127 - Axonics2020-04-06 PNE Lead

Trademark Results [Bulkamid]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BULKAMID
BULKAMID
97797827 not registered Live/Pending
AXONICS WOMEN'S HEALTH LIMITED
2023-02-16
BULKAMID
BULKAMID
85410999 4315566 Live/Registered
Contura A/S
2011-08-30
BULKAMID
BULKAMID
79002593 2998438 Dead/Cancelled
Contura A/S
2004-04-26

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