Solyx™ SIS System

GUDID 08714729784784

SIS System

BOSTON SCIENTIFIC CORPORATION

Stress urinary incontinence surgical mesh, female
Primary Device ID08714729784784
NIH Device Record Key9fe80a91-bf30-4dbe-b5b9-2cb63a63d34b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolyx™ SIS System
Version Model NumberM0068507000
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108714729774044 [Primary]
GS108714729784784 [Package]
Contains: 08714729774044
Package: [5 Units]
In Commercial Distribution

FDA Product Code

PAHmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-04-23
Device Publish Date2015-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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Trademark Results [Solyx]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOLYX
SOLYX
78116296 2681308 Dead/Cancelled
Huyser, Peter
2002-03-20
SOLYX
SOLYX
77950732 3964239 Live/Registered
DECORATIVE FILM, LLC
2010-03-04
SOLYX
SOLYX
77373309 3781679 Live/Registered
Boston Scientific Scimed, Inc.
2008-01-16
SOLYX
SOLYX
76074231 not registered Dead/Abandoned
ANGIOSENSE, Inc.
2000-06-20

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