Soprano AEHC35

GUDID 05708932767781

Coloplast A/S

Gastro-urological guidewire, single-use

• Primary Device ID: 05708932767781
• NIH Device Record Key: 67623a87-5d21-4f70-a758-99241c30d57f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soprano
• Version Model Number: AEHC35
• Catalog Number: AEHC35
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• 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

Device Dimensions

• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch
• Length: 150 Centimeter
• Outer Diameter: 0.035 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932767774 [Primary]
GS1	05708932767781 [Package]; Contains: 05708932767774; Package: Retail Box [5 Units]; In Commercial Distribution
GS1	05708932767798 [Package]; Package: Shipper Box [42 Units]; In Commercial Distribution

FDA Product Code

• OCY: Endoscopic guidewire, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [Soprano]

• 03600040326763: AEHB35
• 03600040326749: AEHA35
• 05708932767811: AEHD35
• 05708932767781: AEHC35