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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 05704101500500 [Primary] |
LNM | Agent, Bulking, Injectable For Gastro-Urology Use |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2020-04-01 |
Device Publish Date | 2020-03-10 |
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 |