Aris 93-4400

GUDID 05708932442961

Trans-Obturator Surgical Kit

Coloplast A/S

Suturing unit, single-use

• Primary Device ID: 05708932442961
• NIH Device Record Key: 1708b868-b162-46c2-89a7-305a90c6b7b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aris
• Version Model Number: 93-4400
• Catalog Number: 93-4400
• 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	05708932442961 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050148

FDA Product Code

• OTN: mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

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: 2015-10-23

Devices Manufactured by Coloplast A/S

• 05708932769334 - Biatain Fiber: 2024-12-20
• 05708932769365 - Biatain Fiber: 2024-12-20
• 05708932769396 - Biatain Fiber: 2024-12-20
• 05708932769426 - Biatain Fiber: 2024-12-20
• 05708932764490 - Biatain Fiber Ag: 2024-12-02
• 05708932764551 - Biatain Fiber Ag: 2024-12-02
• 05708932764568 - Biatain Fiber Ag: 2024-12-02
• 05708932764520 - Biatain Fiber Ag: 2024-12-02