SonoPlex II Facet NRFit 001265-78

GUDID 04048223051450

SonoPlex II Facet NRFit 24G (0,55) x 40mm with injection tube and connecting cable

Pajunk GmbH Medizintechnologie

Nerve-locating anaesthesia needle
Primary Device ID04048223051450
NIH Device Record Key70c37c9e-3195-4a5c-8115-2db1ebada1b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoPlex II Facet NRFit
Version Model Number001265-78
Catalog Number001265-78
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
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

Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 Gauge
Length40 Millimeter
Needle Gauge24 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

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223051450 [Package]
Contains: 04048223072035
Package: [10 Units]
In Commercial Distribution
GS104048223072035 [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 Date2025-07-23
Device Publish Date2025-07-15

On-Brand Devices [SonoPlex II Facet NRFit]

14048223033781SonoPlex II Facet NRFit 20G (0,90) x 150mm, with injection
14048223033453SonoPlex II Facet NRFit 20G (0,90) x 120mm with injection
14048223033323SonoPlex II Facet NRFit 21G (0,80) x 100mm with injection
14048223033316SonoPlex II Facet NRFit 22G (0,70) x 50mm, with injection
14048223033309SonoPlex II Facet NRFit 22G (0,70) x 80mm, with injection
14048223033767SonoPlex II Facet NRFit 22G (0,70) x 40mm, with injection tube and connecting
04048223051450SonoPlex II Facet NRFit 24G (0,55) x 40mm with injection tube and connecting cable
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