FDA UDI
In Commercial Distribution
🇺🇸 United States
TissueGUARD
DI: 42624884400068
·
Model: DMEK Injector SET
·
TissueGUARD GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TissueGUARD
- Primary DI
- 42624884400068
- Version / Model
- DMEK Injector SET
- Catalog Number
- TG-C002
- Company Name
- TissueGUARD GmbH
- Labeler DUNS
- 315250714
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-10
- Public Version
- 1
- Public Version Date
- 2025-04-18
- Public Version Status
- New
- Public Device Record Key
- d2617337-096d-4e01-b1b4-03f6c143a068
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HMX | Cannula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 42624884400068 | GS1 |
Customer Contacts
- Phone
- +4935146531265
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 86 Degrees Fahrenheit