Punctal Occlusion Electrode 1/16" Shaft
EUDAMEDFDA UDIClass IIb (EU MDR)
by Cynosure LLC
Identity
- Trade Name
- PUNCTAL OCCLUSION ELECTRODE 1/16" SHAFT EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- PUNCTAL OCCLUSION ELECTRODE 1/16" SHAFT EUDAMEDFDA UDI
- Model / Reference
- TNAEE330 EUDAMEDFDA UDI
- Description
- PUNCTAL OCCLUSION ELECTRODE 1/16" SHAFT FDA UDI
Identifiers
- Catalog Number
- TNAEE330 FDA UDI
- Primary DI / UDI-DI
- 00841494104306 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841494104306 EUDAMED
- FDA Product Code
- JOS FDA UDI
- EMDN Code
- L180601 OPEN ELECTROSURGERY ELECTRODES, REUSABLE EUDAMED
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The PUNCTAL OCCLUSION ELECTRODE 1/16" SHAFT device is a medical implantable solution used for punctal occlusion, providing temporary or permanent closure of the tear ducts. By creating a small opening in the conjunctiva, it helps to regulate tear drainage and prevent excessive tearing, which can be beneficial for individuals with conditions such as blepharitis or dry eye syndrome.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841494104306 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cynosure LLC
- EUDAMED SRN
- US-MF-000010200
- Authorised Representative
- Cynosure B.V. NL-AR-000009566
Sources (2)
- EUDAMED 4d2cd38a-0455-4784-939c-2eb04985fb4e 61 fields · synced Jun 22, 2026
- FDA UDI e9ab1ef0-794c-4193-942d-060456870e1d 34 fields · synced May 30, 2026