Tuohy

FDA UDI

Class II (US FDA UDI)

by Pajunk GmbH Medizintechnologie

Identity

Trade Name: Tuohy FDA UDI
Generic Name: Epidural needle, non-threaded FDA UDI
Device Name: Tuohy with spec.Point,1cm grad. 17G x 3 1/2" (90mm), plastic stylet FDA UDI
Model / Reference: 1150-6M091 FDA UDI
Description: Tuohy with spec.Point,1cm grad. 17G x 3 1/2" (90mm), plastic stylet FDA UDI

Identifiers

Catalog Number: 1150-6M091 FDA UDI
Primary DI / UDI-DI: 04048223130421 FDA UDI
510(k) Number: K040965 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Epidural needle, non-threaded 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: Outer Diameter — 1.4 Millimeter FDA UDI
Length — 90.0 Millimeter FDA UDI

Category: Epidural needle, non-threaded

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

Similar devices

Also classified as Epidural needle, non-threaded.

Entrada ™ — Boston Scientific Neuromodulation · Class III
CODMAN® — Integra LifeSciences Production Corporation · Class I
Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
Halyard — AVID MEDICAL, INC. · Class II
Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
LCCS — Lccs Products Limited · Class II
Phoenix — DR.JAPAN CO., LTD. · Class II
Phoenix — DR.JAPAN CO., LTD. · Class II

Cleared under the same submission

K040965 also covers:

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 fde9866d-24c9-422b-b234-f6fd3c4c5833 38 fields · synced Jun 8, 2026