FDA.reportPublic FDA data

GYNECARE GYNEMESH

Primary DI
10705031037731
Brand
GYNECARE GYNEMESH
Company
ETHICON, LLC
Model
GPSL
Catalog number
GPSL
Device description
Nonabsorbable Prolene Soft Mesh
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTOMesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTOMesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013718000GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIRGynecare, A Div. of Ethicon, Inc.2002-01-08OTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031037731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503103773110705031037731

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic organ prolapse surgical mesh, synthetic polymerA sterile woven/knitted or porous material comprised of a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031001435ETHILON1629H1629H2015-09-01
10705031006393ETHILON585H585H2015-09-01
10705031007703ETHILON661H661H2015-09-01
10705031007789ETHILON663H663H2015-09-01
10705031007918ETHILON669H669H2015-09-01
10705031008724PERMA-HAND706G706G2015-09-01
10705031129931ETHICONW945W9452026-05-18
10705031239777ETHIBOND EXCELX4B37GX4B37G2018-01-25
10705031239784ETHIBOND EXCELX4B77GX4B77G2018-01-31
10705031462144ETHIBOND EXCEL10X52N10X52N2019-07-04
10705031462168ETHIBOND EXCEL10X72N10X72N2019-07-04
10705031462175ETHIBOND EXCEL10X66N10X66N2019-07-04
10705031468214ETHIBOND EXCELD7576ND7576N2021-05-08
10705031468221ETHIBOND EXCELD10048ND10048N2021-05-08
10705031468238ETHIBOND EXCELD7581ND7581N2021-05-08
10705031468245ETHIBOND EXCELD7924ND7924N2021-05-08
10705031468276ETHIBOND EXCELD8492ND8492N2021-05-08
10705031468320ETHIBOND EXCELD9079ND9079N2021-05-08
10705031468344ETHIBOND EXCELD9329ND9329N2021-05-08
10705031468351ETHIBOND EXCELD9607ND9607N2021-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890594000056Desara Blue SLCaldera Medical, Inc.OTO2022-08-03
00890594000070Desara Blue SLCaldera Medical, Inc.OTO2022-08-03
10705031202795ARTISYNJohnson & Johnson Medical GmbHOTO2019-01-29
00890594000339Vertessa Lite 10x22cm Caldera Medical, Inc.OTO2016-05-27
00890594000391Vertessa Lite Strips 4x22cmCaldera Medical, Inc.OTO2016-05-27
00890594000452Vertessa Lite Y 22x5x4cmCaldera Medical, Inc.OTO2016-05-27
00890594000704Desara Blue OVCaldera Medical, Inc.OTO2016-05-27
00890594000735Desara Blue Short Suture SlingCaldera Medical, Inc.OTO2016-05-27
00890594000643Vertessa Lite 10x22cm CALDERA MEDICAL, INC.OTO2016-05-27
00890594000360Vertessa Lite 10x26cmCaldera Medical, Inc.OTO2016-05-27
00890594000384Vertessa Lite Strips 4x22cmCALDERA MEDICAL, INC.OTO2016-05-27
00890594000421Vertessa Lite Y-mesh 22x4x3cmCaldera Medical, Inc.OTO2016-05-27
00890594000445Vertessa Lite Y 22x5x4cmCALDERA MEDICAL, INC.OTO2016-05-27
00890594000766Desara SLCaldera Medical, Inc.OTO2016-05-27
00890594000698Desara Blue OVCALDERA MEDICAL, INC.OTO2016-05-27
00890594000728Desara Blue Short Suture SlingCALDERA MEDICAL, INC.OTO2016-05-27
00089059400766Desara SLCALDERA MEDICAL, INC.OTO2016-05-27
00890594000674Desara BlueCaldera Medical, Inc.OTO2016-05-26
00890594000797Vertessa Lite Y-Mesh 26x5x4cmCaldera Medical, Inc.OTO2015-10-30
00890594000483Vertessa Lite Y-Mesh 26x4x3cmCaldera Medical, Inc.OTO2015-10-30
00890594000773Vertessa Lite Y-Mesh 26x5x4cmCALDERA MEDICAL, INC.OTO2015-10-30
05708932483223RestorelleColoplast A/SOTO2015-10-24
00814723020333IntePro Y-MeshENDO PHARMACEUTICALS INC.OTO2015-10-24
05708932483285RestorelleColoplast A/SOTO2015-10-22
05708932483834RestorelleColoplast A/SOTO2015-10-22
05708932483896RestorelleColoplast A/SOTO2015-10-22
05708932483964RestorelleColoplast A/SOTO2015-10-22
05708932528108RestorelleColoplast A/SOTO2015-10-22
05708932553773ColoplastColoplast A/SOTO2015-10-22
08714729839217Upsylon™BOSTON SCIENTIFIC CORPORATIONOTO2015-09-24