Wire Electrode Needle Set Female

FDA UDI

Class II (US FDA UDI)

by Laborie Medical Technologies Canada ULC

Identity

Trade Name: Wire Electrode Needle Set Female FDA UDI
Generic Name: Electromyographic needle electrode, single-use FDA UDI
Model / Reference: 1512A-F FDA UDI

Identifiers

Primary DI / UDI-DI: 00627825000499 FDA UDI
FDA Product Code: FEN FDA UDI
GMDN Term: Electromyographic needle electrode, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1620 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

Yes

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

Category: Electromyographic needle electrode, single-use

Wire Electrode Needle Set Female by Laborie Medical Technologies Canada ULC — 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: Laborie Medical Technologies Canada ULC

Sources (1)

FDA UDI b0e0939e-b184-47ac-bc53-0e98b9a834bb 32 fields · synced May 31, 2026