SonoTAP®

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name: SonoTAP® FDA UDI
Generic Name: Peripheral nerve-block sharp needle FDA UDI
Device Name: SonoTAP® 20G x 80mm with bevel tip Cornerstone Reflectors FDA UDI
Model / Reference: 1185-3G080 FDA UDI
Description: SonoTAP® 20G x 80mm with bevel tip Cornerstone Reflectors FDA UDI

Identifiers

Catalog Number: 1185-3G080 FDA UDI
Primary DI / UDI-DI: 04048223076729 FDA UDI
510(k) Number: K113207 FDA UDI
K243525 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Peripheral nerve-block sharp 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 80.0 Millimeter FDA UDI
Needle Gauge — 20.0 Gauge FDA UDI

Category: Peripheral nerve-block sharp needle

SonoTAP® by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pajunk GmbH Medizintechnologie

Sources (1)

FDA UDI bee849c0-1d2a-4f44-8fb8-6899c2876c5e 38 fields · synced May 30, 2026