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Thermi Reusable RF Electrode

FDA UDI

Class II (US FDA UDI)

by Celling Biosciences

Identity

Trade Name
Thermi Reusable RF Electrode FDA UDI
Generic Name
Medium-wave diathermy treatment system electrode, active FDA UDI
Device Name
Thermi 15mm Reusable Non-Invasive RF Electrode FDA UDI
Model / Reference
RFE-15-D-G2 FDA UDI
Description
Thermi 15mm Reusable Non-Invasive RF Electrode FDA UDI

Identifiers

Catalog Number
RFE-15-D-G2 FDA UDI
Primary DI / UDI-DI
00817771029075 FDA UDI
510(k) Number
K130689 FDA UDI
K171094 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Medium-wave diathermy treatment system electrode, active 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medium-wave diathermy treatment system electrode, active

Thermi Reusable RF Electrode by Celling Biosciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medium-wave diathermy treatment system electrode, active.

Cleared under the same submission

K130689 also covers:

K171094 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Celling Biosciences

Sources (1)

  • FDA UDI 236841d4-6c3b-4fb1-9a70-7505891756d3 35 fields · synced May 30, 2026