ProSup

GUDID 10884521177611

Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 cm

Covidien LP

Pelvic organ prolapse surgical mesh, synthetic polymer

• Primary Device ID: 10884521177611
• NIH Device Record Key: c625d419-6f04-4cb7-a6ef-6a30754b38d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSup
• Version Model Number: TECLGK01
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter
• Width: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521177611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982532

FDA Product Code

• FTL: Mesh, surgical, polymeric

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: 2024-05-16
• Device Publish Date: 2015-10-06

On-Brand Devices [ProSup]

• 10884521177611: Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 cm
• 10884521177604: Pelvic Floor Repair Mesh,Polyester,15 cm x 3.5 cm;18 cm x 6 cm