T-Line Hernia Mesh

Basic Information

• Brand Name: T-Line Hernia Mesh
• Primary DI: 00850002394061
• Version / Model: TL3015
• Catalog Number: TL3015
• Company Name: Deep Blue Medical Advances, Inc.
• Labeler DUNS: 079752359
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-30
• Public Version: 1
• Public Version Date: 2020-11-09
• Public Version Status: New
• Public Device Record Key: 69b75d32-2bc6-4d00-a81b-78805c7caea6

Device Description

T-Line Hernia Mesh, 29cm x 15.5cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65117	Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial	A flat or three-dimensional (3-D), woven/knitted material made of non-bioabsorbable synthetic polymer(s) intended for multiple defective tissue repair applications at different anatomical zones (e.g., thoracic, abdominal) that includes an extra-abdominal application(s); it does not include an antimicrobial agent(s), but may include a mesh coating (e.g., titanium, omega 3, monocryl, hyaluronate) intended to supplement mesh performance. It may also be used as a scaffold for tissue regeneration. Disposable devices associated with implantation may be included.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850002394061	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K193144	000