Identity
- Trade Name
- S-16 TIP EUDAMEDPOTENZA Tip FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- S-16 TIP EUDAMEDPOTENZA Tip (Sterile micro needle electrode S-16 tip) FDA UDI
- Model / Reference
- S-16 EUDAMEDFDA UDIS-16 TIP EUDAMED
- Description
- POTENZA Tip (Sterile micro needle electrode S-16 tip) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800020107497 EUDAMED08800020111159 FDA UDI
- Basic UDI-DI
- B-08800020107497 EUDAMED
- 510(k) Number
- K192545 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
- GMDN Term
- Electrosurgical system 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system
POTENZA Tip by Jeisys Medical Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jeisys Medical Inc.
Sources (2)
- FDA UDI c765a76b-c2b2-45d3-bb40-698d0eea5018 34 fields · synced Jul 9, 2026
- EUDAMED 165a2053-1b45-49d0-9f9d-f9a6e5cc82d3 61 fields · synced Jul 9, 2026