FDA.reportPublic FDA data

Alyte™ Y-Mesh Graft

Primary DI
00801741016158
Brand
Alyte™ Y-Mesh Graft
Company
C. R. Bard, Inc.
Model
Y100
Catalog number
Y100
Device description
Alyte™ Y-Mesh Graft
Published
2015-09-14
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741016155PackageGS11Not in Commercial Distribution
00801741016158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101615510801741016155
00801741016158008017410161588017410161580801741016158

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741050817Leg Bag1505071505072020-09-23
00801741076039Catheter Stabilization DeviceVFDSPVFDSP2020-09-22
00801741076053Catheter Stabilization DeviceVFDSSPVFDSSP2020-09-22
00801741076077Catheter Stabilization DeviceFOL0100FOL01002020-09-22
00801741076091Catheter Stabilization DeviceFOL0101FOL01012020-09-22
00801741076114Catheter Stabilization DeviceFOL0102FOL01022020-09-22
00801741076145Catheter Stabilization DeviceFOL0105FOL01052020-09-22
00801741127625Bard® Leg Bag Holders1501111501112016-08-10
00801741127632Bard® Leg Bag Holders1501211501212016-08-10
00801741127649Bard® Leg Bag Holders1501311501312016-08-10
00801741137419Bard® Wide Leg Bag Straps1621101621102018-02-06
00801741137426Bard® Wide Leg Bag Straps1622101622102018-02-06
00801741137433Bard® Wide Leg Bag Straps1623101623102018-02-06
00801741215902StatLock UrologicalSTATURO25STATURO252020-10-23
00801741231025PureWickPW300PCPW300PC2026-05-07
00801741234514PureWickPWA300HPWA300H2026-05-07
00801741225239Elyra708200170820012026-05-06
00801741225246Elyra708200270820022026-05-06
00801741231537PureWickPWKIT03HPWKIT03H2026-05-06
10801741239219PureWickPWF030KXSPWF030KXS2026-05-05

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