Parietex PCOPM20

GUDID 10884521177789

Composite Parastomal Mesh,Monofilament Polyester with Absorbable Collagen Film

SOFRADIM PRODUCTION

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 10884521177789
• NIH Device Record Key: 52eb6e0d-c33e-49da-bc00-b61ec7294186
• Commercial Distribution Discontinuation: 2018-10-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Parietex
• Version Model Number: PCOPM20
• Catalog Number: PCOPM20
• 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

Device Dimensions

• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 Centimeter
• Outer Diameter: 20 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 *
• 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 *
• 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 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521177789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081126

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: 2019-10-29
• Device Publish Date: 2015-10-06

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• 10884521178892: Lightweight Mesh Monofilament Polyester
• 20884521178844: Lightweight Mesh,Monofilament Polyester
• 10884521180277: Hydrophilic 2-Dimensional Mesh,Polyester
• 10884521179851: Optimized Composite Mesh, Polyester with Absorbable Collagen Film
• 10884521179844: Optimized Composite Mesh, Polyester with Absorbable Collagen Film
• 10884521179837: Optimized Composite Mesh,Polyester with Absorbable Collagen Film
• 10884521179820: Optimized Composite Mesh,Skirted Polyester Mesh with Absorbable Collagen Film
• 10884521179813: Optimized Composite Mesh,Skirted Polyester Mesh with Absorbable Collagen Film
• 10884521179783: Optimized Composite Mesh,Polyester with Absorbable Collagen Film and Pre-placed Sutures
• 10884521179752: Optimized Composite Mesh,Polyester with Absorbable Collagen Film
• 10884521179714: Optimized Composite Mesh,Skirted Polyester Mesh with Absorbable Collagen Film
• 10884521179691: Optimized Composite Mesh,Polyester with Absorbable Collagen Film and Pre-placed Sutures
• 10884521179684: Optimized Composite Mesh,Polyester with Absorbable Collagen Film and Pre-placed Sutures
• 10884521179677: Optimized Composite Mesh,Skirted Polyester Mesh with Absorbable Collagen Film
• 10884521179660: Optimized Composite Mesh,Polyester with Absorbable Collagen Film
• 10884521179653: Optimized Composite Mesh,Polyester with Absorbable Collagen Film
• 20884521178868: Lightweight Mesh,Monofilament Polyester
• 10884521178854: Lightweight Mesh,Monofilament Polyester
• 10884521177789: Composite Parastomal Mesh,Monofilament Polyester with Absorbable Collagen Film
• 10884521177772: Composite Parastomal Mesh,Monofilament Polyester with Absorbable Collagen Film
• 10884521177765: Composite Parastomal Mesh,Monofilament Polyester with Absorbable Collagen Film
• 10884521178939: Lightweight Mesh,Monofilament Polyester
• 10884521178878: Lightweight Mesh,Monofilament Polyester
• 10884521165724: Composite Ventral Patch;Polyester & Polyglycolic-Lactic Acid Patch with Absorbable Collagen Film
• 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
• 10884521180284: Hydrophilic 2-Dimensional Mesh,Polyester
• 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
• 10884521178922: Lightweight Mesh,Monofilament Polyester
• 10884521178465: Composite Mesh,Polyester with Absorbable Collagen Film
• 10884521180352: Hydrophilic 3-Dimensional Mesh,Polyester
• 10884521180345: Hydrophilic 3-Dimensional Mesh,Polyester
• 10884521180260: Hydrophilic 2-Dimensional Mesh,Polyester