Secret RF Set Package

FDA UDI

Class II (US FDA UDI)

by CLASSYS Inc.

Identity

Trade Name: Secret RF Set Package FDA UDI
Generic Name: Intradermal radio-frequency ablation system FDA UDI
Model / Reference: MTR-C1 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800016903287 FDA UDI
510(k) Number: K170325 FDA UDI
FDA Product Code: GEI FDA UDI
OUH FDA UDI
GMDN Term: Intradermal radio-frequency ablation 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intradermal radio-frequency ablation system

Secret RF Set Package by CLASSYS Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K170325 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

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Manufacturer

Manufacturer: CLASSYS Inc.

Sources (1)

FDA UDI 81c09f40-10ae-401a-ba70-fdc018c12f65 33 fields · synced Jun 8, 2026