← Back to catalogue

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 21G x 31/2" (90mm), with IntroDucer NRFit 30mm and wing FDA UDI
Model / Reference
321163-31A FDA UDI
Description
SPROTTE® NRFit 21G x 31/2" (90mm), with IntroDucer NRFit 30mm and wing FDA UDI

Identifiers

Catalog Number
321163-31A FDA UDI
Primary DI / UDI-DI
04048223127117 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 — 0.8 Millimeter FDA UDI
Length — 90.0 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

Similar devices

Also classified as Spinal needle, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Pajunk GmbH Medizintechnologie

Sources (1)

  • FDA UDI e4c3e9ae-520f-4bc9-a4d1-dec62b56ec0c 37 fields · synced May 30, 2026