Bulkamid

GUDID 10810005340493

Bulkamid 3mL

AXONICS MODULATION TECHNOLOGIES, INC.

Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable

• 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

Customer Support Contacts

• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com
• Phone: +1 (877) 929-6642
• Email: customersupport@axonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10810005340493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170023

FDA Product Code

• LNM: Agent, Bulking, Injectable For Gastro-Urology Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by AXONICS MODULATION TECHNOLOGIES, INC.

• 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
• 10810005340141 - Axonics: 2020-04-06 Tined Lead Kit