Parietex TECR1510AR

GUDID 10884521180024

Hydrophilic Anatomical Mesh,Right Side, Polyester

SOFRADIM PRODUCTION

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

• Primary Device ID: 10884521180024
• NIH Device Record Key: efd942e4-fd3e-4e5a-a45e-e24bd24d8670
• Commercial Distribution Discontinuation: 2018-02-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Parietex
• Version Model Number: TECR1510AR
• Catalog Number: TECR1510AR
• 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

Device Dimensions

• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 15 Centimeter
• Width: 10 Centimeter
• Length: 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 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521180024 [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: 6
• Public Version Date: 2022-06-10
• Device Publish Date: 2015-10-06

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