POTENZA Tip

FDA UDI

Class II (US FDA UDI)

by Jeisys Medical Inc.

Identity

Trade Name: POTENZA Tip FDA UDI
Generic Name: Electrosurgical system FDA UDI
Device Name: POTENZA Tip (Sterile micro needle electrode A1-12 Tip) FDA UDI
Model / Reference: A1-12 FDA UDI
Description: POTENZA Tip (Sterile micro needle electrode A1-12 Tip) FDA UDI

Identifiers

Primary DI / UDI-DI: 08800020111265 FDA UDI
510(k) Number: K192545 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Electrosurgical system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K192545 also covers:

POTENZA — Jeisys Medical Inc.
POTENZA Tip — Jeisys Medical Inc.
POTENZA Tip — Jeisys Medical Inc.
POTENZA Tip — Jeisys Medical Inc.
POTENZA Tip — Jeisys Medical Inc.
POTENZA Tip — Jeisys Medical Inc.
POTENZA Tip — Jeisys Medical Inc.
POTENZA Tip — Jeisys Medical Incorporated

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 II	Pending data

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Manufacturer

Manufacturer: Jeisys Medical Inc.

Sources (1)

FDA UDI d3f92aa9-aa18-4142-a97a-704b1b2a9695 34 fields · synced May 30, 2026