ProGrip LPG1510X2

GUDID 10884521513143

Laproscopic Self-Fixing Mesh

SOFRADIM PRODUCTION

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 10884521513143
• NIH Device Record Key: d32dd6e2-7ec1-490e-a5c4-7bf4a34ccd09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGrip
• Version Model Number: LPG1510X2
• Catalog Number: LPG1510X2
• 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
• 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
• 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: 10 Centimeter
• Length: 15 Centimeter
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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 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 111 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521513143 [Primary]
GS1	10884521513266 [Package]; Package: CASE [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142900

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: 2020-10-21
• Device Publish Date: 2016-04-16

On-Brand Devices [ProGrip]

• 10884521177710: Self-Gripping Polyester Mesh,Right Anatomical, Polyester with Polylactic Acid Grips
• 10884521177703: Self-Gripping Polyester Mesh,Left Anatomical, Polyester with Polylactic Acid Grips
• 10884521513143: Laproscopic Self-Fixing Mesh
• 10884521177741: Self-Gripping Polyester Mesh,Polyester with Polylactic Acid Grips
• 10884521177734: Self-Gripping Polyester Mesh,Polyester with Polylactic Acid Grips
• 10884521177727: Self-Gripping Polyester Mesh,Polyester with Polylactic Acid Grips
• 10884521177697: Self-Gripping Polyester Mesh,Right Anatomical, Polyester with Polylactic Acid Grips
• 10884521177680: Self-Gripping Polyester Mesh,Left Anatomical, Polyester with Polylactic Acid Grips
• 10884521177673: Self-Gripping Polyester Mesh,Polyester with Polylactic Acid Grips
• 10884521177666: Self-Gripping Polypropylene Mesh Right Anatomical, Polypropylene with Polylactic Acid Grips
• 10884521177659: Self-Gripping Polypropylene Mesh Left Anatomical, Polypropylene with Polylactic Acid Grips
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