Deflux®

GUDID 00365649922039

Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.

SALIX PHARMACEUTICALS, LTD.

Urinary tract reconstructive material, microbe-derived
Primary Device ID00365649922039
NIH Device Record Key9ed694b5-66f3-4c21-ab35-02ab802f841c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeflux®
Version Model Number1092203
Company DUNS793108036
Company NameSALIX PHARMACEUTICALS, LTD.
Device Count1
DM Exemptfalse
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com
Phone8005080024
Emailsalix@medcomsol.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100365649922039 [Primary]
GS110365649922036 [Package]
Package: Transport Box [96 Units]
In Commercial Distribution

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 Date2014-10-31

Devices Manufactured by SALIX PHARMACEUTICALS, LTD.

00365649850035 - Solesta®2018-07-06 SOLESTA® is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative thera
00365649922039 - Deflux®2018-07-06Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.
00365649922039 - Deflux®2018-07-06 Deflux® is a bulking agent indicated for treatment of children with vesicoureteral reflux (VUR) grades II-IV.

Trademark Results [Deflux]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DEFLUX
DEFLUX
77118595 3458947 Live/Registered
NESTLÉ SKIN HEALTH S.A.
2007-02-28
DEFLUX
DEFLUX
75505567 2274215 Live/Registered
NESTLÉ SKIN HEALTH S.A.
1998-06-19

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