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Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc.

Identity

Trade Name
Epimed FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Device Name
R-F™ Flare 18g 10cm w/ 10mm Coudé® Active Tip FDA UDI
Model / Reference
220-1810 FDA UDI
Description
R-F™ Flare 18g 10cm w/ 10mm Coudé® Active Tip FDA UDI

Identifiers

Catalog Number
220-1810 FDA UDI
Primary DI / UDI-DI
00818788023209 FDA UDI
510(k) Number
K041021 FDA UDI
FDA Product Code
GXI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4725 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

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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 10 Centimeter FDA UDI
Needle Gauge — 18 Gauge FDA UDI
Length — 10 Millimeter FDA UDI

Category: Percutaneous radio-frequency ablation probe cannula, single-use

Epimed by Epimed International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Percutaneous radio-frequency ablation probe cannula, single-use.

Cleared under the same submission

K041021 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epimed International, Inc.

Sources (1)

  • FDA UDI ccc70dd9-0b17-4d4f-8582-74d5462975ba 38 fields · synced Jun 4, 2026