SonoTAP II NRFit 1265-3F150

GUDID 04048223057360

SonoTAP II NRFit 21G x 150mm with bevel tip and Cornerstone Reflectors

Pajunk GmbH Medizintechnologie

Peripheral nerve-block sharp needle
Primary Device ID04048223057360
NIH Device Record Keyd3b2ed83-9ce9-4cdb-9de6-eae5e49c265a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoTAP II NRFit
Version Model Number1265-3F150
Catalog Number1265-3F150
Company DUNS317654283
Company NamePajunk GmbH Medizintechnologie
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
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

Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge
Length150 Millimeter
Needle Gauge21 Gauge

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
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
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
GS104048223057360 [Package]
Contains: 04048223077948
Package: [10 Units]
In Commercial Distribution
GS104048223077948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-07
Device Publish Date2025-06-27

On-Brand Devices [SonoTAP II NRFit]

14048223033835SonoTAP II NRFit 21G x 110mm with bevel tip and Cornerstone Re
14048223033828SonoTAP II NRFit 22G x 80mm with bevel tip and Cornerstone Re
14048223033811SonoTAP II NRFit 22G x 50mm with bevel tip and Cornerstone Re
04048223129586SonoTAP II NRFit 21G x 110mm with bevel tip and Cornerstone Reflectors
04048223057384SonoTAP II NRFit 24G x 50mm with bevel tip and Cornerstone Reflectors
04048223057377SonoTAP II NRFit 24G x 40mm with bevel tip and Cornerstone Reflectors
04048223057360SonoTAP II NRFit 21G x 150mm with bevel tip and Cornerstone Reflectors
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.