T-Line Hernia Mesh TL3015

GUDID 00850002394061

T-Line Hernia Mesh, 29cm x 15.5cm

Deep Blue Medical Advances, Inc.

Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial

• Primary Device ID: 00850002394061
• NIH Device Record Key: 69b75d32-2bc6-4d00-a81b-78805c7caea6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Line Hernia Mesh
• Version Model Number: TL3015
• Catalog Number: TL3015
• Company DUNS: 079752359
• Company Name: Deep Blue Medical Advances, Inc.
• 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: 833-833-3725
• Email: cs@deepbluemedical.com
• Phone: 833-833-3725
• Email: cs@deepbluemedical.com
• Phone: 833-833-3725
• Email: cs@deepbluemedical.com
• Phone: 833-833-3725
• Email: cs@deepbluemedical.com
• Phone: 833-833-3725
• Email: cs@deepbluemedical.com
• Phone: 833-833-3725
• Email: cs@deepbluemedical.com
• Phone: 833-833-3725
• Email: cs@deepbluemedical.com
• Phone: 833-833-3725
• Email: cs@deepbluemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002394061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193144

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: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [T-Line Hernia Mesh]

• 00850002394078: T-Line Hernia Mesh, 29cm x 20.5cm
• 00850002394061: T-Line Hernia Mesh, 29cm x 15.5cm
• 00850002394054: T-Line Hernia Mesh, 29cm x 10.5cm
• 00850002394047: T-Line Hernia Mesh, 29cm x 5.5cm
• 00850002394030: T-Line Hernia Mesh, 13.5cm x 20.5cm
• 00850002394023: T-Line Hernia Mesh, 13.5cc x 15.5cm
• 00850002394016: T-Line Hernia Mesh, 13.5cm x 10.5cm
• 00850002394009: T-Line Hernia Mesh, 13.5cm x 5.5cm