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Sprotte®

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
SPROTTE® FDA UDI
Generic Name
Spinal needle, single-use FDA UDI
Device Name
Needle FDA UDI
Model / Reference
121163-30A FDA UDI
Description
Needle FDA UDI

Identifiers

Catalog Number
121163-30A FDA UDI
Primary DI / UDI-DI
04048223113394 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

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

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.55 Millimeter FDA UDI
Length — 90.0 Millimeter FDA UDI

Category: Spinal needle, single-use

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

Similar devices

Also classified as Spinal needle, single-use.

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 42b5bd56-ca68-4b55-98e6-431ca2983370 37 fields · synced May 30, 2026