Identity
- Trade Name
- TissueGUARD FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- DMEK Injector SET FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- TG-C002 FDA UDI
- Primary DI / UDI-DI
- 42624884400068 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
TissueGUARD by TissueGUARD GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TissueGUARD GmbH
Sources (1)
- FDA UDI d2617337-096d-4e01-b1b4-03f6c143a068 36 fields · synced May 30, 2026