TissueGUARD TG-C001

GUDID 04262488440037

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.

TissueGUARD GmbH

Surgical instrument guard, single-use

• Primary Device ID: 04262488440037
• NIH Device Record Key: e92dc86f-f679-4bd7-af8a-4b70d838cafd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TissueGUARD
• Version Model Number: DMEK/DSAEK Washing GUARD
• Catalog Number: TG-C001
• Company DUNS: 315250714
• Company Name: TissueGUARD GmbH
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de
• Phone: +4935146531265
• Email: info@tissueguard.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04262488440037 [Unit of Use]
GS1	04262488440044 [Primary]

FDA Product Code

• LXZ: Guard, Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-05
• Device Publish Date: 2025-04-25

On-Brand Devices [TissueGUARD]

• 42624884400068: The TissueGUARD DMEK Injector SET is a sterile, single-use system for Descemet Membrane Endothel
• 04262488440013: Tip Closure Cap for DMEK Injector. Single-use, disposable accessory to TissueGUARD DMEK Injector
• 04262488440037: Sterile, single-use, disposable accessory to TissueGUARD DMEK Injector cannula. The intended use