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INTRAgen Tip

FDA UDI

Class II (US FDA UDI)

by Jeisys Medical Inc.

Identity

Trade Name
INTRAgen Tip FDA UDI
Generic Name
Radio-frequency skin contouring system applicator tip FDA UDI
Device Name
Sterile electrode FDA UDI
Model / Reference
KT-07 FDA UDI
Description
Sterile electrode FDA UDI

Identifiers

Primary DI / UDI-DI
08800020105028 FDA UDI
510(k) Number
K142833 FDA UDI
FDA Product Code
OUH FDA UDI
GEI FDA UDI
GMDN Term
Radio-frequency skin contouring system applicator tip 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Radio-frequency skin contouring system applicator tip

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

Similar devices

Also classified as Radio-frequency skin contouring system applicator tip.

Cleared under the same submission

K142833 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Jeisys Medical Inc.

Sources (1)

  • FDA UDI ebec6460-460c-4e45-96ad-2760686d4316 34 fields · synced May 30, 2026