GYNECARE GYNEMESH GPSL

GUDID 20705031037738

Nonabsorable PROLENE, soft mesh

ETHICON, LLC

Pelvic organ prolapse surgical mesh, synthetic polymer

• Primary Device ID: 20705031037738
• NIH Device Record Key: 1035cba1-f71b-4e05-bd97-ec8a34e0d0c0
• Commercial Distribution Discontinuation: 2020-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GYNECARE GYNEMESH
• Version Model Number: GPSL
• Catalog Number: GPSL
• Company DUNS: 829465157
• Company Name: ETHICON, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031037738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013718

FDA Product Code

• OTO: Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-01
• Device Publish Date: 2015-09-23

On-Brand Devices [GYNECARE GYNEMESH]

• 20705031037738: Nonabsorable PROLENE, soft mesh
• 10705031037748: Nonabsorable PROLENE, soft mesh
• 10705031037731: Nonabsorbable Prolene Soft Mesh