Transorb

GUDID 10884521809727

Self-Gripping Resorbable Mesh Monofilament PLLA/TMC Textile and Grips

SOFRADIM PRODUCTION

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

• Primary Device ID: 10884521809727
• NIH Device Record Key: e99c249f-8f6d-44b2-bf12-7385a2160416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transorb
• Version Model Number: TSB3030
• 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
• 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

• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter
• Height: 30 Centimeter
• Length: 30 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521809727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233661

FDA Product Code

• OWT: Mesh, surgical, absorbable, abdominal hernia

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: 2024-03-18
• Device Publish Date: 2024-03-08

On-Brand Devices [Transorb]

• 10884521809734: Self-Gripping Resorbable Mesh Monofilament PLLA/TMC Textile and Grips
• 10884521809727: Self-Gripping Resorbable Mesh Monofilament PLLA/TMC Textile and Grips
• 10884521809710: Self-Gripping Resorbable Mesh Monofilament PLLA/TMC Textile and Grips
• 10884521809703: Self-Gripping Resorbable Mesh Monofilament PLLA/TMC Textile and Grips