RFTL Sono 001175-11D

GUDID 04048223050484

RFTL Sono 20G x 52,6 mm with Cornerstone reflectors

Pajunk GmbH Medizintechnologie

Percutaneous radio-frequency ablation probe cannula, single-use
Primary Device ID04048223050484
NIH Device Record Key131ef249-9b7f-4cb7-84e5-e20dc54988b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRFTL Sono
Version Model Number001175-11D
Catalog Number001175-11D
Company DUNS317654283
Company NamePajunk GmbH Medizintechnologie
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com
Phone+1 770-493-6832
Emailinfo@pajunk-usa.com

Device Dimensions

Needle Gauge20 Gauge
Length52.6 Millimeter
Needle Gauge20 Gauge
Length52.6 Millimeter
Needle Gauge20 Gauge
Length52.6 Millimeter
Needle Gauge20 Gauge
Length52.6 Millimeter
Needle Gauge20 Gauge
Length52.6 Millimeter
Needle Gauge20 Gauge
Length52.6 Millimeter
Needle Gauge20 Gauge
Length52.6 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223050484 [Package]
Contains: 04048223071069
Package: [25 Units]
In Commercial Distribution
GS104048223071069 [Primary]

FDA Product Code

GXIProbe, radiofrequency lesion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-07
Device Publish Date2025-01-30

On-Brand Devices [RFTL Sono]

14048223026080RFTL Sono 22G x 98,6mm with Cornersto
14048223024642RFTL Sono 22G x 98,6mm, with Cornersto
04048223026083001175-20B
04048223024645001175-20A
04048223050484RFTL Sono 20G x 52,6 mm with Cornerstone reflectors

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.