TissueGUARD TG-C002

GUDID 42624884400068

The TissueGUARD DMEK Injector SET is a sterile, single-use system for Descemet Membrane Endothelial Keratoplasty (DMEK), in which a human donor graft of Descemet's membrane with endothelium is transplanted subsequent to the removal of the recipient's Descemet's membrane. The TissueGUARD DMEK INJECTOR SET can be used for DMEK in children, adolescents, and adults. The main part of the system is an ophthalmic cannula with corresponding supporting accessories.

TissueGUARD GmbH

Ophthalmic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 42624884400068
• NIH Device Record Key: d2617337-096d-4e01-b1b4-03f6c143a068
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TissueGUARD
• Version Model Number: DMEK Injector SET
• Catalog Number: TG-C002
• Company DUNS: 315250714
• Company Name: TissueGUARD GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	42624884400068 [Primary]

FDA Product Code

• HMX: Cannula, Ophthalmic

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: 2025-04-18
• Device Publish Date: 2025-04-10

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