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Epimed

FDA UDI

Class II (US FDA UDI)

by Minta Medical Limited

Identity

Trade Name
Epimed FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use FDA UDI
Device Name
Adapter Assembly Disposable R-F™ Probe, Baylis Intermediate FDA UDI
Model / Reference
296-DPIA06B FDA UDI
Description
Adapter Assembly Disposable R-F™ Probe, Baylis Intermediate FDA UDI

Identifiers

Catalog Number
296-DPIA06B FDA UDI
Primary DI / UDI-DI
05060224334560 FDA UDI
510(k) Number
K090608 FDA UDI
FDA Product Code
GXI FDA UDI
GMDN Term
Percutaneous radio-frequency ablation probe, denervation, monopolar, 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

Category: Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use

Epimed by Minta Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K090608 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Minta Medical Limited

Sources (1)

  • FDA UDI 48de9726-e1f6-4f73-8509-bbad37d7bdec 37 fields · synced May 30, 2026