Durasphere ® EXP 890-215

GUDID 00858015005004

Injectable Bulking Agent

Carbon Medical Technologies, Inc.

Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
Primary Device ID00858015005004
NIH Device Record Keyece80d63-45e3-4a00-a618-97e4a651cb00
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurasphere ® EXP
Version Model Number890-215
Catalog Number890-215
Company DUNS883094039
Company NameCarbon Medical Technologies, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8882070262
Emailinfo@carbonmed.com

Device Dimensions

Total Volume1 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit
Handling Environment TemperatureBetween 60 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100858015005004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNMAgent, Bulking, Injectable For Gastro-Urology Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2014-09-17

On-Brand Devices [Durasphere ® EXP ]

00858015005011Injectable Bulking Agent
00858015005004Injectable Bulking Agent

Trademark Results [Durasphere]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURASPHERE
DURASPHERE
87479253 not registered Dead/Abandoned
Kyocera International, Inc.
2017-06-07
DURASPHERE
DURASPHERE
75574354 2373853 Live/Registered
Advanced UroScience, Inc.
1998-10-21

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