FDA.reportPublic FDA data

SonoPlex II

Primary DI
14048223036546
Brand
SonoPlex II
Company
Pajunk GmbH Medizintechnologie
Model
001285-31G
Catalog number
001285-31G
Device description
SonoPlex II with Sprotte tip 22G (0,70) x 50mm with injection tube and connecting cable
Published
2018-11-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223036546PrimaryGS10
04048223036549Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822303654614048223036546
04048223036549040482230365494048223036549

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating anaesthesia needleA sterile device intended to functions as: 1) an electrode during nerve/nerve plexus location; and 2) as a conduit for administration of a local anaesthetic during peripheral nerve-blocking. It is a sharp, hollow, tubular, electrically-insulated metal needle with an uninsulated bevelled tip, intended to be used with an electrical pulse generator and an appropriate anaesthetic-filled syringe. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
10
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223084366EpiLong Soft NRFit1432167-511432167-512026-05-21
04048223122235Stim2Go9151-10-009151-10-002026-05-21
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
14048223031312NiniFilter NRFit001163-38K001163-38K2020-07-22
14048223041793Filter NRFit001163-39F001163-39F2020-07-22
04048223048917FILTER001151-37X001151-37X2021-04-02
04048223049877FILTER001163-38K001163-38K2021-04-02
04048223050064FILTER001163-39F001163-39F2021-04-02
04048223069462Flat filter 0,2µm round001151-37Q001151-37Q2025-01-30
04048223069585MiniFilter 0,2µm001151-38K001151-38K2025-01-30
04048223070598Filter cannula NRFit001163-38Y001163-38Y2025-01-30
04048223120316Filter001151-62001151-622025-04-04
14048223016593Filter 0,2µm001151-37X001151-37X2016-09-29
14048223018993Quincke1149-3E1201149-3E1202020-11-03
14048223032777Tuohy cannula1150-7G1031150-7G1032020-06-09
14048223034443Tuohy1150-4G1031150-4G1032020-11-16
14048223036720UniMSK1192-4E1201192-4E1202020-07-02
14048223036737UniMSK1192-4E1501192-4E1502020-07-02
14048223038946Tuohy1150-4E1201150-4E1202020-05-06
14048223038953Tuohy1150-4G1201150-4G1202020-07-02

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Primary DI, Brand, Company table
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10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
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