Parietene PPMK1106X3

GUDID 20884521214887

Macroporous Mesh, Monofilament Polypropylene

SOFRADIM PRODUCTION

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 20884521214887
• NIH Device Record Key: e1d7afd2-8c70-4d4c-ad47-92a30615f576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parietene
• Version Model Number: PPMK1106X3
• Catalog Number: PPMK1106X3
• 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
• 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

• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter
• Length: 11 Centimeter
• Width: 6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521214880 [Primary]
GS1	20884521214887 [Package]; Contains: 10884521214880; Package: CS [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142091

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: 6
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-06-01

On-Brand Devices [Parietene]

• 10884521213739: Macroporous Mesh, Monofilament Polypropylene
• 20884521214887: Macroporous Mesh, Monofilament Polypropylene
• 10884521213784: Macroporous Mesh, Monofilament Polypropylene