Altis 519650

GUDID 05708932467407

Single Incision Sling System

Coloplast A/S

Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Stress urinary incontinence surgical mesh, female Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer Female stress urinary incontinence surgical mesh-sling, synthetic polymer

• Primary Device ID: 05708932467407
• NIH Device Record Key: efa6727d-4434-4253-ab86-684e45067bb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altis
• Version Model Number: 519650
• Catalog Number: 519650
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• 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(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com
• Phone: +1(800)258-3476
• Email: urology@coloplast.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932467407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121562

FDA Product Code

• PAH: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-10-22

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