Solesta®

GUDID 00365649850035

Anal tissue reconstructive material

Primary Device ID	00365649850035
NIH Device Record Key	deb3c664-29a9-4a16-8813-38ea2ffe3bbb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Solesta®
Version Model Number	1085003
Company DUNS	793108036
Company Name	SALIX PHARMACEUTICALS, LTD.
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	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	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00365649850035 [Primary]
GS1	10365649850032 [Package] Package: Transport box [32 Units] In Commercial Distribution

LNM	Agent, Bulking, Injectable For Gastro-Urology Use

Steralize Prior To Use	false
Device Is Sterile	true

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

Mark Image Registration \| Serial	Company Trademark Application Date
SOLESTA 90465463 not registered Live/Pending	Galderma Holding S.A. 2021-01-14
SOLESTA 88090466 not registered Live/Pending	NÃ©stlÃ© Skin Health S.A. 2018-08-23
SOLESTA 78853445 3352167 Dead/Cancelled	NESTLÃ SKIN HEALTH S.A. 2006-04-04