202257-000 Needle, Mono Kit Ambu CA CE

FDA UDI

Class II (US FDA UDI)

by Ambu A/S

Identity

Trade Name: 202257-000 Needle, Mono Kit Ambu CA CE FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Device Name: Cadwell Neuroline Monopolar Kit FDA UDI
Model / Reference: 743-CAD/SET FDA UDI
Description: Cadwell Neuroline Monopolar Kit FDA UDI

Identifiers

Catalog Number: 743-CAD/SET FDA UDI
Primary DI / UDI-DI: 05707480109715 FDA UDI
FDA Product Code: GXZ FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1350 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Yes

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

FDA UDI

Dimensions & Sizes

Size: Length — 38 Centimeter FDA UDI
Length — 50 Centimeter FDA UDI
Length — 25 Centimeter FDA UDI

Category: Electromyographic needle electrode, single-use

202257-000 Needle, Mono Kit Ambu CA CE by Ambu A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Ambu A/S

Sources (1)

FDA UDI 1328f0b7-3262-4ede-9691-3e6da2677461 37 fields · synced Jun 1, 2026