FDA.reportPublic FDA data

Solyx™ Blue

Primary DI
08714729961901
Brand
Solyx™ Blue
Company
BOSTON SCIENTIFIC CORPORATION
Model
M0068507010
Device description
SIS System
Published
2018-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PAHmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAHMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729961901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729961901087147299619018714729961901

GMDN Terms#

Term, Definition table
TermDefinition
Stress urinary incontinence surgical mesh, femaleA sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24
08714729716204Ultraflex™ Esophageal NGM005138302015-09-24
00191506067342TruSelect™M00139735105010M001397351050102026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437007606058Needleless SlingDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLPAH2020-10-19
00890594000957Desara One Caldera Medical, Inc.PAH2020-02-25
00890594000971Desara One Caldera Medical, Inc.PAH2020-02-25
28032919892120T-SLINGHERNIAMESH SRLPAH2016-08-05
00814723020036MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020104MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
00814723020364MiniArcENDO PHARMACEUTICALS INC.PAH2015-10-24
05708932467407AltisColoplast A/SPAH2015-10-22
08714729774044Solyx™ SIS SystemBOSTON SCIENTIFIC CORPORATIONPAH2015-09-24
08714729784784Solyx™ SIS System BOSTON SCIENTIFIC CORPORATIONPAH2015-09-24