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E-Cath acc. Tsui

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
E-Cath acc. Tsui FDA UDI
Generic Name
Peripheral anaesthesia catheter set, non-medicated FDA UDI
Device Name
E-Cath acc. Tsui SonoPlex Stim cannula 21G x 101mm indwelling catheter 18G x 83mm FDA UDI
Model / Reference
241285-40E FDA UDI
Description
E-Cath acc. Tsui SonoPlex Stim cannula 21G x 101mm indwelling catheter 18G x 83mm FDA UDI

Identifiers

Catalog Number
241285-40E FDA UDI
Primary DI / UDI-DI
14048223025632 FDA UDI
510(k) Number
K152952 FDA UDI
FDA Product Code
BSO FDA UDI
GMDN Term
Peripheral anaesthesia catheter set, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5120 FDA UDI
Commercial Distribution
Not 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

Yes

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

E-Cath acc. Tsui by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K152952 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 a216ccf5-9bbd-4f9c-8cb6-58406d84c331 37 fields · synced Jun 8, 2026