FDA.reportPublic FDA data

Bulkamid

Primary DI
10810005340509
Brand
Bulkamid
Company
AXONICS MODULATION TECHNOLOGIES, INC.
Model
50050
Device description
Bulkamid Urethral Bulking System 2mL
Published
2023-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNMAgent, Bulking, Injectable For Gastro-Urology Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNMAgent, Bulking, Injectable For Gastro-Urology UseUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810005340509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081000534050910810005340509

GMDN Terms#

Term, Definition table
TermDefinition
Urinary tract reconstructive material, synthetic polymer, non-bioabsorbableA sterile, implantable, non-bioabsorbable synthetic material (e.g., hydrophilic polyacrylamide gel) intended for submucosal injection in the urinary tract (urethra, urinary bladder, and/or distal ureter) to add volume by serving as a space-occupying supplement (bulking agent) to the intercellular matrix of connective tissue in the treatment of stress urinary incontinence (SUI) and/or vesicoureteral reflux (VUR). It is in the form of a gel material typically preloaded in a disposable syringe and is implanted using an endoscope and/or other dedicated instruments.

Contacts#

Phone, Email table
PhoneEmail
+1 877 929 6642customersupport@axonics.com

Regulatory Flags#

DUNS number
079562449
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810005340424Axonics9108-R2020-11-03
10810005340431Axonics9108-E2020-11-03
10810005340233Axonics900590052019-09-23
10810005340264Axonics9008-R9008-R2019-09-23
10810005340271Axonics9008-E9008-E2019-09-23
10810005340011Axonics140114012019-09-23
10810005340370Axonics140114012019-09-23
10810005340387Axonics140114012019-09-23
10810005340479Axonics510151012023-09-08
10810005340455Axonics410141012022-03-11
10810005340066Axonics110111012019-09-23
10810005340523AxonicsFFG-01FFG-012025-02-05
10810005340578Axonics900990092024-07-29
10810005340493Bulkamid600302023-08-30
10810005340486Axonics901590152022-06-14
10810005340035Axonics250125012019-09-23
10810005340059Axonics160116012019-09-23
10810005340080Axonics180118012019-09-23
10810005340103Axonics230123012019-09-23
10810005340127Axonics190119012019-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810235030645CoaptiteMERZ NORTH AMERICA, INC.LNM2024-10-15
10810005340493BulkamidAXONICS MODULATION TECHNOLOGIES, INC.LNM2023-08-30
05704101500500BulkamidContura International A/SLNM2020-03-10
00850004725023Deflux Metal NeedlePALETTE LIFE SCIENCES, INC.LNM2019-02-11
00850004725009DefluxPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00850004725016SolestaPALETTE LIFE SCIENCES, INC.LNM2019-02-01
00365649850035Solesta®SALIX PHARMACEUTICALS, LTD.LNM2014-10-31
00365649922039Deflux®SALIX PHARMACEUTICALS, LTD.LNM2014-10-31
08714729804796CoaptiteMERZ NORTH AMERICA, INC.LNM2014-09-17
00858015005004Durasphere ® EXP Carbon Medical Technologies, Inc.LNM2014-09-17
00858015005011Durasphere ® EXPCarbon Medical Technologies, Inc.LNM2014-09-17
08717591240266Macroplastique ImplantsUroplasty, Inc.LNM2014-06-20