SonoPlex II Facet NRFit

Basic Information

• Brand Name: SonoPlex II Facet NRFit
• Primary DI: 14048223033767
• Version / Model: 001265-70
• Catalog Number: 001265-70
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-05-29
• Public Version: 2
• Public Version Date: 2021-03-16
• Public Version Status: Update
• Public Device Record Key: 077b4ac5-7e6a-47d8-b0b0-a5f345e3afa2
• Distribution End Date: 2025-03-15

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)	Anesthesiology	868.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61546	Nerve-locating anaesthesia needle	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14048223033767	GS1
Unit of Use	04048223033760	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]