Epimed International, Inc.

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc

Identity

Trade Name: Epimed International, Inc. FDA UDI
Generic Name: Epidural needle, non-threaded FDA UDI
Device Name: Plastic L.O.R./ 18g x 3.5" Tuohy FDA UDI
Model / Reference: 197-3518 FDA UDI
Description: Plastic L.O.R./ 18g x 3.5" Tuohy FDA UDI

Identifiers

Catalog Number: 197-3518 FDA UDI
Primary DI / UDI-DI: 00818788020543 FDA UDI
510(k) Number: K030562 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

Yes

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

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 3.5 Inch FDA UDI
Needle Gauge — 18 Gauge FDA UDI

Category: Epidural needle, non-threaded

Epimed International, Inc. by Epimed International, Inc — 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

K030562 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: Epimed International, Inc

Sources (1)

FDA UDI 91ffae06-c966-4ba4-a706-7323b272ef78 37 fields · synced Jun 8, 2026