Parietex TCM1515

GUDID 10884521178878

Lightweight Mesh,Monofilament Polyester

SOFRADIM PRODUCTION

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 10884521178878
• NIH Device Record Key: e0de9897-6548-4002-8c61-9384fbed1515
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Parietex
• Version Model Number: TCM1515
• Catalog Number: TCM1515
• 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

Device Dimensions

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521178878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090858

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: 5
• Public Version Date: 2019-06-20
• Device Publish Date: 2015-10-06

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• 10884521180369: Hydrophilic 3-Dimensional Mesh,Polyester
• 10884521180307: Hydrophilic 2-Dimensional Mesh,Polyester
• 10884521180116: Hydrophilic 2-Dimensional Mesh,Polyester
• 10884521180109: Hydrophilic 2-Dimensional Mesh,Polyester
• 10884521179950: Hydrophilic Anatomical Mesh,Right Side, Polyester
• 10884521177758: Composite Parastomal Mesh,Monofilament Polyester with Absorbable Collagen Film
• 10884521180314: Hydrophilic 2-Dimensional Mesh,Polyester
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• 10884521180253: Hydrophilic 2-Dimensional Mesh,Polyester
• 10884521180239: Hydrophilic Anatomical Mesh,Left Side, Polyester
• 10884521180215: Hydrophilic Anatomical Mesh,Right Side, Polyester
• 10884521180130: Hydrophilic 3-Dimensional Mesh,Polyester
• 10884521180093: Hydrophilic 2-Dimensional Mesh,Polyester
• 10884521180048: Hydrophilic 2-Dimensional Mesh,Polyester
• 10884521179967: Hydrophilic Anatomical Mesh,Right Side, Polyester
• 10884521179868: Optimized Composite Mesh,Skirted Polyester Mesh with Absorbable Collagen Film
• 10884521179738: Optimized Composite Mesh,Polyester with Absorbable Collagen Film and Pre-placed Sutures
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• 10884521180260: Hydrophilic 2-Dimensional Mesh,Polyester