Tridyne™ Vascular Sealant Standard Spray Tips

Basic Information

• Brand Name: Tridyne™ Vascular Sealant Standard Spray Tips
• Primary DI: 10801741099370
• Version / Model: TDST0020
• Catalog Number: TDST0020
• Company Name: NEOMEND, INC.
• Labeler DUNS: 195251595
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-10-31
• Public Version: 3
• Public Version Date: 2021-01-08
• Public Version Status: Update
• Public Device Record Key: d580f863-ac42-4d95-b5ae-4d008511af43

Device Description

Tridyne Vascular Sealant Standard Spray Tips

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: Yes
• 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
NBE	Sealant,polymerizing	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801741099377	GS1	CA	10	In Commercial Distribution
Primary	10801741099370	GS1
Unit of Use	00801741099373	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150016	000