Plastic BD Style Hub Tuohy Epidural Needle

FDA UDI

Class II (US FDA UDI)

by Spectra Medical Devices, LLC

Identity

Trade Name: Plastic BD Style Hub Tuohy Epidural Needle FDA UDI
Generic Name: Epidural needle, non-threaded FDA UDI
Device Name: Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 3.50", Plastic Stylet, Marks, No Wing, Luer Connector FDA UDI
Model / Reference: S103418-3.50LT FDA UDI
Description: Plastic BD Style Hub Tuohy Epidural Needle, 18G Special x 3.50", Plastic Stylet, Marks, No Wing, Luer Connector FDA UDI

Identifiers

Primary DI / UDI-DI: M661S103418350 FDA UDI
510(k) Number: K854816 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

Yes

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

FDA UDI

Category: Epidural needle, non-threaded

Plastic BD Style Hub Tuohy Epidural Needle by Spectra Medical Devices, LLC — 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 — Pajunk GmbH Medizintechnologie · Class II
TuohySono — Pajunk GmbH Medizintechnologie · Class II
Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
LCCS — Lccs Products Limited · Class II

Cleared under the same submission

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: Spectra Medical Devices, LLC

Sources (1)

FDA UDI 8bee3356-633e-4328-9b19-36bd13512dce 34 fields · synced Jun 9, 2026