INTRAgen

FDA UDI

Class II (US FDA UDI)

by Jeisys Medical Incorporated

Identity

Trade Name: INTRAgen FDA UDI
Generic Name: Electrosurgical system FDA UDI
Device Name: Electrosurgical unit FDA UDI
Model / Reference: INTRAgen FDA UDI
Description: Electrosurgical unit FDA UDI

Identifiers

Primary DI / UDI-DI: 08800020105011 FDA UDI
510(k) Number: K142833 FDA UDI
FDA Product Code: OUH FDA UDI
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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical system

INTRAgen by Jeisys Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical system.

Bovie — BOVIE MEDICAL CORPORATION · Class II
Macan — Macan Manufacturing · Class II
Macan — Macan Manufacturing · Class II
T4 Fine wire electrode — BONART CO., LTD. · Class II
DIEGO ELITE — Gyrus Acmi, Inc. · Class II
Macan — Macan Manufacturing · Class II
DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
Bovie — BOVIE MEDICAL CORPORATION · Class II

Cleared under the same submission

K142833 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Jeisys Medical Incorporated

Sources (1)

FDA UDI 73f95257-60c6-4f78-8eb4-d20caee5c121 34 fields · synced Jun 8, 2026