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NeuroTrace

FDA UDI

Class II (US FDA UDI)

by Neo Medical Inc.

Identity

Trade Name
NeuroTrace FDA UDI
Generic Name
Peripheral anaesthesia catheter set, non-medicated FDA UDI
Device Name
Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 2.0" (51mm), Tuohy Bevel FDA UDI
Model / Reference
557-18-05 FDA UDI
Description
Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 2.0" (51mm), Tuohy Bevel FDA UDI

Identifiers

Catalog Number
557-18-05 FDA UDI
Primary DI / UDI-DI
B33955718050 FDA UDI
510(k) Number
K994059 FDA UDI
FDA Product Code
CAZ FDA UDI
GMDN Term
Peripheral anaesthesia catheter set, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5140 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 — 51 Millimeter FDA UDI
Length — 2.0 Inch FDA UDI
Needle Gauge — 18 Gauge FDA UDI

Category: Peripheral anaesthesia catheter set, non-medicated

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

Similar devices

Also classified as Peripheral anaesthesia catheter set, non-medicated.

Cleared under the same submission

K994059 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 97d23363-f0d8-40cf-bd2a-6506cedba7ca 38 fields · synced Jun 1, 2026