Bulkamid
GUDID 05704101500500
Bulkamid Urethral Bulking System
Contura International A/S
Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use Urological surgical procedure kit, non-medicated, single-use| Primary Device ID | 05704101500500 |
| NIH Device Record Key | 41bd2db8-69d5-4d6d-831b-636c69a8e7df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bulkamid |
| Version Model Number | 50050 |
| Company DUNS | 308200307 |
| Company Name | Contura International A/S |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
| Storage Environment Temperature | Between 0 Degrees Celsius and 0 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from direct sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05704101500500 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-04-01 |
| Device Publish Date | 2020-03-10 |
Trademark Results [Bulkamid]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.