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Sonoplex

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
SONOPLEX FDA UDI
Generic Name
Nerve-locating anaesthesia needle FDA UDI
Device Name
NanoLineCornerStonesProximal End: ISO 80369-7 FDA UDI
Model / Reference
001185-77 FDA UDI
Description
NanoLineCornerStonesProximal End: ISO 80369-7 FDA UDI

Identifiers

Catalog Number
001185-77 FDA UDI
Primary DI / UDI-DI
04048223103494 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

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.8 Millimeter FDA UDI
Length — 100.0 Millimeter FDA UDI

Category: Nerve-locating anaesthesia needle

Sonoplex 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9c79acb5-c4d7-4d6d-97ef-23b7ecbfe567 37 fields · synced Jun 8, 2026