Dextile DXT1612AL

GUDID 10884521726543

Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side

SOFRADIM PRODUCTION

Abdominal hernia 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: 10884521726543
• NIH Device Record Key: 08656ce0-a7bc-4ef8-8eb1-c48357891026
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dextile
• Version Model Number: DXT1612AL
• Catalog Number: DXT1612AL
• Company DUNS: 576342646
• Company Name: SOFRADIM PRODUCTION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

Device Dimensions

• Width: 16 Centimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Width: 16 Centimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Width: 16 Centimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Width: 16 Centimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Width: 16 Centimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Width: 16 Centimeter
• Length: 12 Centimeter
• Device Size Text, specify: 0
• Width: 16 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No
• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521726543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192443

FDA Product Code

• FTL: Mesh, surgical, polymeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-20
• Device Publish Date: 2020-01-10

On-Brand Devices [Dextile]

• 10884521726543: Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side
• 10884521726536: Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side
• 10884521726529: Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side
• 10884521726512: Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side
• 10884521726505: Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Left Side
• 10884521726499: Anatomical Mesh Pre-shaped Monofilament Polypropylene Textile with Marking;Right Side