FDA UDI
In Commercial Distribution
🇺🇸 United States
TissueGUARD
DI: 04262488440020
·
Model: Tip Closure Cap for DMEK Injector
·
TissueGUARD GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- TissueGUARD
- Primary DI
- 04262488440020
- Version / Model
- Tip Closure Cap for DMEK Injector
- Catalog Number
- TG-C003
- Company Name
- TissueGUARD GmbH
- Labeler DUNS
- 315250714
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-04-24
- Public Version
- 1
- Public Version Date
- 2025-05-02
- Public Version Status
- New
- Public Device Record Key
- 94943ee8-5307-4043-817f-ebfb7d17911e
Device Description
Tip Closure Cap for DMEK Injector. Single-use, disposable accessory to TissueGUARD DMEK Injector cannula. The intended use is to prevent the liquid flow from the cannula. There is no direct contact with the tissue. The device does not have any clinical indication.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXZ | Guard, Instrument | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63247 | Surgical instrument guard, single-use | A device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04262488440013 | GS1 | ||||
| Primary | 04262488440020 | GS1 |
Customer Contacts
- Phone
- +4935146531265
- [email protected]