Alyte™ Y
Alyte™ Y-Mesh Graft - Y500
Device Description
A 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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OTO
Device Name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class: 2
Physical State: synthetic woven or non-woven fabric of varying material properties (e.g., density, pore size, weave, resorption, etc.); design can be pre-configured for specific repair or can be a sheet to allow surgeon to cut mesh to desired size and shape
Definition: Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
Submission Type ID: 1
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: permanent implant placed transabdominally that provides mechanical support and/or serves as a bridging material for suspending the vaginal apex or uterus from the sacral promontory.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: vagina, uterus, sacrum
Regulation Number: 878.3300
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 10801741016162
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00801741016165
Package Quantity: 5
Package Discontinue Date: 12/31/2016 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: CA
Device Id: 00801741016165
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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