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Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc

Identity

Trade Name
Epimed FDA UDI
Generic Name
Epidural needle, non-threaded FDA UDI
Device Name
Plastic L.O.R./ 22g RW x 3.5" Tuohy FDA UDI
Model / Reference
196-3022 FDA UDI
Description
Plastic L.O.R./ 22g RW x 3.5" Tuohy FDA UDI

Identifiers

Catalog Number
196-3022 FDA UDI
Primary DI / UDI-DI
00818788021687 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 22 Gauge FDA UDI
Length — 3.5 Inch FDA UDI

Category: Epidural needle, non-threaded

Epimed is a high-quality, single-use epidural needle designed for precise delivery of anaesthetic or analgesic agents into the epidural space. This sterile, sharp bevel-edged, hollow tubular metal instrument features a non-threaded design and is intended for implantable use in needled procedures.

Similar devices

Also classified as Epidural needle, non-threaded.

Cleared under the same submission

K030562 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Epimed International, Inc

Sources (1)

  • FDA UDI 63bbf426-b65b-4162-aab2-ee92fa337a16 38 fields · synced Jun 22, 2026