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NeuroTrace

FDA UDI

Class II (US FDA UDI)

by Neo Medical Inc.

Identity

Trade Name
NeuroTrace FDA UDI
Generic Name
Nerve-locating anaesthesia needle FDA UDI
Device Name
Insulated Electro-Needle for use in Regional Anesthesia, 22ga x 5.0" (127mm), B Bevel FDA UDI
Model / Reference
553-22-12 FDA UDI
Description
Insulated Electro-Needle for use in Regional Anesthesia, 22ga x 5.0" (127mm), B Bevel FDA UDI

Identifiers

Catalog Number
553-22-12 FDA UDI
Primary DI / UDI-DI
B33955322120 FDA UDI
510(k) Number
K032981 FDA UDI
FDA Product Code
BSP FDA UDI
GMDN Term
Nerve-locating anaesthesia 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 127 Millimeter FDA UDI
Length — 5.0 Inch FDA UDI
Needle Gauge — 22 Gauge FDA UDI

Category: Nerve-locating anaesthesia needle

NeuroTrace by Neo Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve-locating anaesthesia needle.

Cleared under the same submission

K032981 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neo Medical Inc.

Sources (1)

  • FDA UDI 54429150-80db-4901-a0b7-793a87f64348 38 fields · synced Jun 6, 2026