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Standard Sprotte Needle

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name
Standard Sprotte Needle FDA UDI
Generic Name
Spinal needle, single-use FDA UDI
Device Name
Standard Sprotte Needle 20G x 4 3/4" (120mm) sterile, with Introducer and wings FDA UDI
Model / Reference
321151-31B FDA UDI
Description
Standard Sprotte Needle 20G x 4 3/4" (120mm) sterile, with Introducer and wings FDA UDI

Identifiers

Catalog Number
321151-31B FDA UDI
Primary DI / UDI-DI
04048223128077 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

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0.9 Millimeter FDA UDI
Length — 120.0 Millimeter FDA UDI

Category: Spinal needle, single-use

Standard Sprotte Needle 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 ac8a73ac-fdd1-4b95-abcf-82d3acda93fb 37 fields · synced Jun 8, 2026