Disposable Biopsy Needle

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name: Disposable Biopsy Needle FDA UDI
Generic Name: Brain biopsy procedure kit FDA UDI
Device Name: Disposable Biopsy Needle 2.1 x 190 mm for Leksell Frame FDA UDI
Model / Reference: 42053-01 FDA UDI
Description: Disposable Biopsy Needle 2.1 x 190 mm for Leksell Frame FDA UDI

Identifiers

Catalog Number: 42053-01 FDA UDI
Primary DI / UDI-DI: 04048223099032 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Brain biopsy procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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 Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.1 Millimeter FDA UDI
Length — 190.0 Millimeter FDA UDI

Category: Brain biopsy procedure kit

Disposable Biopsy Needle by Pajunk GmbH Medizintechnologie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 1b61cd3c-7dd1-4cf0-a8c7-0a153dd4a895 37 fields · synced Jun 1, 2026