SPROTTE® NRFit

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name: SPROTTE® NRFit FDA UDI
Generic Name: Spinal needle, single-use FDA UDI
Device Name: SPROTTE® NRFit 24G x 4" (103mm) with IntroDucer NRFit 40mm FDA UDI
Model / Reference: 021163-30A FDA UDI
Description: SPROTTE® NRFit 24G x 4" (103mm) with IntroDucer NRFit 40mm FDA UDI

Identifiers

Catalog Number: 021163-30A FDA UDI
Primary DI / UDI-DI: 04048223127889 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Spinal needle, single-use 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

Dimensions & Sizes

Size: Length — 103.0 Millimeter FDA UDI
Outer Diameter — 0.55 Millimeter FDA UDI

Category: Spinal needle, single-use

SPROTTE® NRFit 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 fd318b74-2c90-47df-aaf4-25bfe49b97bf 37 fields · synced May 30, 2026