AccessGUDID - DEVICE: TissueGUARD (42624884400068)

GUDID

Device Identifier (DI) Information

Brand Name: TissueGUARD
Version or Model: DMEK Injector SET
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TG-C002
Company Name: TissueGUARD GmbH

Primary DI Number: 42624884400068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315250714 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	Cannula, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Temperature: between 50 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2617337-096d-4e01-b1b4-03f6c143a068
Public Version Date: April 18, 2025
Public Version Number: 1
DI Record Publish Date: April 10, 2025