| Primary Device ID | 04262488440013 |
| NIH Device Record Key | 94943ee8-5307-4043-817f-ebfb7d17911e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TissueGUARD |
| Version Model Number | Tip Closure Cap for DMEK Injector |
| Catalog Number | TG-C003 |
| Company DUNS | 315250714 |
| Company Name | TissueGUARD GmbH |
| Device Count | 10 |
| 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 |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de | |
| Phone | +4935146531265 |
| info@tissueguard.de |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04262488440013 [Unit of Use] |
| GS1 | 04262488440020 [Primary] |
| LXZ | Guard, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
[04262488440013]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-02 |
| Device Publish Date | 2025-04-24 |
| 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 |