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SonoPlex II Facet NRFit

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
SonoPlex II Facet NRFit FDA UDI
Generic Name
Nerve-locating anaesthesia needle FDA UDI
Device Name
SonoPlex II Facet NRFit 24G (0,55) x 40mm with injection tube and connecting cable FDA UDI
Model / Reference
001265-78 FDA UDI
Description
SonoPlex II Facet NRFit 24G (0,55) x 40mm with injection tube and connecting cable FDA UDI

Identifiers

Catalog Number
001265-78 FDA UDI
Primary DI / UDI-DI
04048223072035 FDA UDI
510(k) Number
K243682 FDA UDI
FDA Product Code
BSP FDA UDI
GMDN Term
Nerve-locating anaesthesia needle FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 40.0 Millimeter FDA UDI
Needle Gauge — 24.0 Gauge FDA UDI

Category: Nerve-locating anaesthesia needle

SonoPlex II Facet NRFit by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve-locating anaesthesia needle.

Cleared under the same submission

K243682 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pajunk GmbH Medizintechnologie

Sources (1)

  • FDA UDI 70c37c9e-3195-4a5c-8115-2db1ebada1b1 38 fields · synced May 30, 2026