Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc.

Identity

Trade Name: Epimed FDA UDI
Generic Name: Peripheral nerve-block blunt needle FDA UDI
Device Name: 20g TW x 2.0" Blunt Nerve Block Needle FDA UDI
Model / Reference: 116-2020 FDA UDI
Description: 20g TW x 2.0" Blunt Nerve Block Needle FDA UDI

Identifiers

Primary DI / UDI-DI: 00818788023636 FDA UDI
510(k) Number: K041843 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Peripheral nerve-block blunt needle 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

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 2.0 Inch FDA UDI
Needle Gauge — 20 Gauge FDA UDI

Category: Peripheral nerve-block blunt needle

Epimed by Epimed International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral nerve-block blunt needle.

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Ultraplex 360® — B. BRAUN MEDICAL INC. · Class II
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Halyard — Avanos Medical, Inc. · Class II
Ultraplex 360® — B. BRAUN MEDICAL INC. · Class II
Chiba-Type Spinal Needle — HAKKO CO., LTD. · Class II
Nerve Block Needle — HAKKO CO., LTD. · Class II
Stimuplex® Ultra 360® — B. BRAUN MEDICAL INC. · Class II

Cleared under the same submission

K041843 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 920fc7af-ebf5-41bc-b23c-6b5cb3404dd1 36 fields · synced Jun 4, 2026