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SonoTAP II NRFit

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
SonoTAP II NRFit FDA UDI
Generic Name
Peripheral nerve-block sharp needle FDA UDI
Device Name
SonoTAP II NRFit 22G x 50mm with bevel tip and Cornerstone Reflectors FDA UDI
Model / Reference
1265-3E050 FDA UDI
Description
SonoTAP II NRFit 22G x 50mm with bevel tip and Cornerstone Reflectors FDA UDI

Identifiers

Catalog Number
1265-3E050 FDA UDI
Primary DI / UDI-DI
04048223126240 FDA UDI
510(k) Number
K113207 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

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

Category: Peripheral nerve-block sharp needle

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

Similar devices

Also classified as Peripheral nerve-block sharp needle.

Cleared under the same submission

K113207 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 b879c3cf-0bba-4aa5-bdcf-5c4a6233b97e 37 fields · synced Jun 8, 2026