COAPTIUM® Connect

Basic Information

• Brand Name: COAPTIUM® Connect
• Primary DI: 03760279380117
• Version / Model: NCOCO3010
• Catalog Number: NCOCO3010
• Company Name: TISSIUM
• Labeler DUNS: 265137228
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-22
• Public Version: 1
• Public Version Date: 2025-09-30
• Public Version Status: New
• Public Device Record Key: 7dfa93e1-5849-4fdd-908a-81e5939341fd

Device Description

Sutureless Nerve Coaptation System COAPTIUM® CONNECT is a bioabsorbable coaptation system for sutureless peripheral nerve repair of peripheral nerves not in continuity. The system includes a single-use syringe pre-filled with a photoactive COAPTIUM® polymer which is used to secure an implantable three-dimensional coaptation chamber to the nerve segments that are distal and proximal to a peripheral nerve injury.

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: MR Safe
• 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
SFD	In Situ Polymerizing Peripheral Nerve Repair Device	Neurology	882.5270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44814	Nerve guide, synthetic polymer, bioabsorbable	An implantable device intended to be used 1) to create a tunnel through which a discontinuous peripheral nerve can regenerate to bridge the proximal and distal nerve ends, 2) to encase a nerve for protection to aid in repair [e.g., to prevent ingrowth of scar tissue], or 3) for capping the end of an amputated nerve to prevent the formation of a neuroma. It is made of bioabsorbable synthetic polymer(s) in the form of a solid tube or a gel which polymerises in situ, and is designed to be chemically degraded and absorbed via natural body processes. It is also known as a nerve sheath, nerve cuff, nerve protector, nerve conduit, nerve wrap, or nerve cap.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760279380117	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.0	Millimeter
Length	10	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Should be stored in a clean, dry location at room temperature, and away from sunlight. The package should not be exposed to extreme temperatures for extended periods of time and should not be frozen.