AccessGUDID - DEVICE: SonoPlex® II Facet S NRFit (04048223072134)

GUDID

Device Identifier (DI) Information

Brand Name: SonoPlex® II Facet S NRFit
Version or Model: 001267-88
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001267-88
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223072134
Issuing Agency: GS1
Commercial Distribution End Date: July 16, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: SonoPlex® II Facet S NRFit 21G (0,80) x 80mm, Facet tip S with injection tube and connecting cable

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243682	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 80.0 Millimeter
Needle Gauge: 21.0 Gauge

Device Record Status

Public Device Record Key: 5889408c-bea6-4ff0-906e-855860b5bbce
Public Version Date: July 23, 2025
Public Version Number: 1
DI Record Publish Date: July 15, 2025