SERI

GUDID B6119467909

SERI Surgical Scaffold 5cm x 15cm

SOFREGEN MEDICAL INC.

Multi-purpose surgical mesh, silk, bioabsorbable Multi-purpose surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable Extra-gynaecological surgical mesh, silk, bioabsorbable

• Primary Device ID: B6119467909
• NIH Device Record Key: cf5269c6-f55b-43e6-944e-b6fddf89dd80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SERI
• Version Model Number: 94680
• Company DUNS: 079710838
• Company Name: SOFREGEN MEDICAL INC.
• 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com
• Phone: 617 651 8871
• Email: prodsurv@sofregen.com

Device Dimensions

• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter
• Width: 5 Centimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B6119467909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123128

FDA Product Code

• OXF: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-02

On-Brand Devices [SERI]

• B6119468001: SERI Surgical Scaffold 10cm x 25cm
• B6119467909: SERI Surgical Scaffold 5cm x 15cm
• B6119467808: SERI Surgical Scaffold 20cm x 30cm
• B6119467707: SERI Surgical Scaffold 15cm x 25cm