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: SPROTTE® 27G x 4" (103mm) with magnification and Introducer, sterile FDA UDI
Model / Reference: 141151-27A FDA UDI
Description: SPROTTE® 27G x 4" (103mm) with magnification and Introducer, sterile FDA UDI

Identifiers

Catalog Number: 141151-27A FDA UDI
Primary DI / UDI-DI: 04048223130056 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 — 0.4 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.

Phoenix — DR.JAPAN CO., LTD. · Class II
RELI — MYCO MEDICAL SUPPLIES INC. · Class II
Phoenix — DR.JAPAN CO., LTD. · Class II
LCCS — Lccs Products Limited · Class II
Phoenix — DR.JAPAN CO., LTD. · Class II
Phoenix — DR.JAPAN CO., LTD. · Class II
Spinocan® — B. BRAUN MEDICAL INC. · Class II
Temena — Te ME NA Sas · Class II

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

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

Manufacturer

Manufacturer: Pajunk GmbH Medizintechnologie

Sources (1)

FDA UDI 104b0dc9-df8f-4f20-b53e-6c5e16c1a457 37 fields · synced Jun 1, 2026