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Epimed International, Inc.

FDA UDIEUDAMED

Class II (US FDA UDI)

by Epimed International, Inc

Identity

Trade Name
Epimed International, Inc. FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Device Name
RF™ Coudé® B Bevel 20g x 5cm with 10mm Active Tip FDA UDI
Model / Reference
233-2005 FDA UDI
Description
RF™ Coudé® B Bevel 20g x 5cm with 10mm Active Tip FDA UDI

Identifiers

Catalog Number
233-2005 FDA UDI
Primary DI / UDI-DI
00818788021434 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
Not 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 — 15 Millimeter FDA UDI
Length — 10 Centimeter FDA UDI
Needle Gauge — 20 Gauge FDA UDI

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

Cleared under the same submission

K041021 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epimed International, Inc

Sources (2)

  • FDA UDI c07e9e72-67ec-42f5-a4c4-681dab4e5fa6 38 fields · synced Jun 20, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026