RFTL - RFTL 22G x - Pajunk GmbH Medizintechnologie

Duns Number:317654283

Device Description: RFTL 22G x 98,6mm, stimulatio RFTL 22G x 98,6mm, stimulation tip 10mm, grinding 15°,

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More Product Details

Catalog Number

001165-20C

Brand Name

RFTL

Version/Model Number

001165-20C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 15, 2025

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GXI

Product Code Name

PROBE, RADIOFREQUENCY LESION

Device Record Status

Public Device Record Key

b09e52df-637d-4b29-864d-aeeb0e081234

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PAJUNK GMBH MEDIZINTECHNOLOGIE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 979