Duatene DTN1610EX6

GUDID 20884521726649

Bilayer Mesh Monofilament Polypropylene

SOFRADIM PRODUCTION

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: 20884521726649
• NIH Device Record Key: c91a32f9-7ab3-4677-9c82-0f235050c07e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duatene
• Version Model Number: DTN1610EX6
• Catalog Number: DTN1610EX6
• 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

Device Dimensions

• Height: 6 Centimeter
• Device Size Text, specify: 0
• Width: 13 Centimeter
• Height: 6 Centimeter
• Device Size Text, specify: 0
• Width: 13 Centimeter
• Height: 6 Centimeter
• Device Size Text, specify: 0
• Width: 13 Centimeter
• Height: 6 Centimeter
• Device Size Text, specify: 0
• Width: 13 Centimeter
• Height: 6 Centimeter
• Device Size Text, specify: 0
• Width: 13 Centimeter
• Height: 6 Centimeter
• Device Size Text, specify: 0
• Width: 13 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521726642 [Primary]
GS1	20884521726649 [Package]; Contains: 10884521726642; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172395

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: 2022-06-10
• Device Publish Date: 2018-03-12

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