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Rftl

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
RFTL FDA UDI
Generic Name
Percutaneous radio-frequency ablation probe cannula, single-use FDA UDI
Device Name
RFTL curved 20G x 145mm stimulation tip 10mm, grinding 15°, FDA UDI
Model / Reference
011165-32CM FDA UDI
Description
RFTL curved 20G x 145mm stimulation tip 10mm, grinding 15°, FDA UDI

Identifiers

Catalog Number
011165-32CM FDA UDI
Primary DI / UDI-DI
04048223130575 FDA UDI
510(k) Number
K060397 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

No

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

Rftl by Pajunk GmbH Medizintechnologie — 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

K060397 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pajunk GmbH Medizintechnologie

Sources (1)

  • FDA UDI 0c2b6452-c240-48f3-bfd4-79dc23284932 37 fields · synced Jun 8, 2026