SonoPlex® II Facet S NRFit 001267-70

GUDID 04048223132623

SonoPlex® II Facet S NRFit 22G (0,70) x 40mm, Facet tip S with injection tube and connecting cable

Pajunk GmbH Medizintechnologie

Nerve-locating anaesthesia needle
Primary Device ID04048223132623
NIH Device Record Keyaa8f3bc7-78f5-423c-9727-0142df8ab387
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoPlex® II Facet S NRFit
Version Model Number001267-70
Catalog Number001267-70
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
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

Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter
Outer Diameter0.7 Millimeter
Length40 Millimeter

Operating and Storage Conditions

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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104048223051467 [Previous]
GS104048223131244 [Primary]
GS104048223132623 [Package]
Contains: 04048223131244
Package: [10 Units]
In Commercial Distribution

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 Date2025-06-25
Device Publish Date2025-06-17

On-Brand Devices [SonoPlex® II Facet S NRFit]

04048223132623SonoPlex® II Facet S NRFit 22G (0,70) x 40mm, Facet tip S with injection tube and connecting ca
04048223132593SonoPlex® II Facet S NRFit 22G (0,70) x 50mm, Facet tip S with injection tube and connecting ca
04048223132586SonoPlex® II Facet S NRFit 22G (0,70) x 80mm, Facet tip S with injection tube and connecting ca

Trademark Results [SonoPlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SONOPLEX
SONOPLEX
79294227 not registered Live/Pending
Pajunk GmbH Medizintechnologie
2020-07-02
SONOPLEX
SONOPLEX
72088340 0704513 Dead/Cancelled
SONNEBORN CHEMICAL AND REFINING CORPORATION
1959-12-31

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