TissueGUARD

Basic Information

• Brand Name: TissueGUARD
• Primary DI: 04262488440044
• Version / Model: DMEK/DSAEK Washing GUARD
• Catalog Number: TG-C001
• Company Name: TissueGUARD GmbH
• Labeler DUNS: 315250714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-04-25
• Public Version: 1
• Public Version Date: 2025-05-05
• Public Version Status: New
• Public Device Record Key: e92dc86f-f679-4bd7-af8a-4b70d838cafd

Device Description

Sterile, single-use, disposable accessory to TissueGUARD DMEK Injector cannula. The intended use is to control the liquid flow from the cannula during the washing of the DMEK or DSAEK tissue within the device. There is no direct contact with the tissue. The device does not have any clinical indication.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
LXZ	Guard, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63247	Surgical instrument guard, single-use	A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04262488440037	GS1
Primary	04262488440044	GS1

Customer Contacts

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