Exair 50100

GUDID 05708932459457

Prolapse Repair System - Anterior

Coloplast A/S

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• Primary Device ID: 05708932459457
• NIH Device Record Key: 53de6045-aad4-47da-9d8f-e9fc2047a6eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exair
• Version Model Number: 50100
• Catalog Number: 50100
• 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	05708932459457 [Primary]

FDA Product Code

• OTP: Mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally 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: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-10-22

On-Brand Devices [Exair]

• 05708932459457: Prolapse Repair System - Anterior
• 05708932459433: Prolapse Repair System - Posterior