AccessGUDID - DEVICE: Bulkamid (10810005340509)

GUDID

Device Identifier (DI) Information

Brand Name: Bulkamid
Version or Model: 50050
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AXONICS MODULATION TECHNOLOGIES, INC.

Primary DI Number: 10810005340509
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079562449 *Terms of Use

Device Description: Bulkamid Urethral Bulking System 2mL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60704	Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LNM	Agent, Bulking, Injectable For Gastro-Urology Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 049ba0ae-863f-40df-941d-a4966e0f75a6
Public Version Date: December 18, 2024
Public Version Number: 2
DI Record Publish Date: September 12, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 877 929 6642
Email: customersupport@axonics.com

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