Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc.

Identity

Trade Name: Epimed FDA UDI
Generic Name: Peripheral nerve-block sharp needle FDA UDI
Device Name: 25g X 4.5" Nerve Block Needle Quincke Tip FDA UDI
Model / Reference: 131-2545 FDA UDI
Description: 25g X 4.5" Nerve Block Needle Quincke Tip FDA UDI

Identifiers

Catalog Number: 131-2545 FDA UDI
Primary DI / UDI-DI: 00818788023469 FDA UDI
510(k) Number: K022029 FDA UDI
FDA Product Code: BSP FDA UDI
GMDN Term: Peripheral nerve-block sharp 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

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

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 25 Gauge FDA UDI
Length — 4.5 Inch FDA UDI

Category: Peripheral nerve-block sharp needle

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Cleared under the same submission

K022029 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 9649ddab-f832-4f7f-be7b-b7e945eaf7f0 38 fields · synced Jun 22, 2026