Parietene DS PPDS15

GUDID 10884521795402

Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking

SOFRADIM PRODUCTION

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 10884521795402
• NIH Device Record Key: 33e1757f-e7e5-434c-b842-77af90597c40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parietene DS
• Version Model Number: PPDS15
• Catalog Number: PPDS15
• Company DUNS: 576342646
• Company Name: SOFRADIM PRODUCTION
• 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
• 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

• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521795402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163212

FDA Product Code

• FTL: Mesh, surgical, polymeric

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: 2020-02-03
• Device Publish Date: 2020-01-26

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