Primary Device ID | 00858015005011 |
NIH Device Record Key | 3661de57-9aec-4590-b2da-92e53ba23bdb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Durasphere ® EXP |
Version Model Number | 890-216 |
Catalog Number | 890-216 |
Company DUNS | 883094039 |
Company Name | Carbon Medical Technologies, Inc. |
Device Count | 1 |
DM Exempt | true |
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 | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 8882070262 |
info@carbonmed.com |
Total Volume | 3 Milliliter |
Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Handling Environment Temperature | Between 60 Degrees Fahrenheit and 90 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858015005011 [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 | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2014-09-17 |
00858015005011 | Injectable Bulking Agent |
00858015005004 | Injectable Bulking Agent |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DURASPHERE 87479253 not registered Dead/Abandoned |
Kyocera International, Inc. 2017-06-07 |
DURASPHERE 75574354 2373853 Live/Registered |
Advanced UroScience, Inc. 1998-10-21 |