B3 GEL System

Basic Information

• Brand Name: B3 GEL System
• Primary DI: 00860011716730
• Version / Model: B3TNP04061
• Company Name: Tybr Health, Inc.
• Labeler DUNS: 117403452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-17
• Public Version: 1
• Public Version Date: 2025-12-25
• Public Version Status: New
• Public Device Record Key: 27b3d409-a09b-440d-8898-5da50b373cae

Device Description

B3 GEL System - 4 mL / 6 cm

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: Yes
• 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
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	878.3300	2
FTM	Mesh, Surgical	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35671	Tendon spacer	An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011716730	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K250109	000