Myo/Wire

FDA UDI

Class II (US FDA UDI)

by A & E Medical Corporation

Identity

Trade Name: Myo/Wire FDA UDI
Generic Name: Transthoracic pacing lead FDA UDI
Device Name: Temp Pacing Wire FDA UDI
Model / Reference: 025-301 FDA UDI
Description: Temp Pacing Wire FDA UDI

Identifiers

Primary DI / UDI-DI: 10841291100409 FDA UDI
510(k) Number: K803086 FDA UDI
FDA Product Code: LDF FDA UDI
GMDN Term: Transthoracic pacing lead FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3680 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Transthoracic pacing lead

Myo/Wire by A & E Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: A & E Medical Corporation

Sources (1)

FDA UDI 9ebf42e7-ca55-407f-9974-60b69ada2f64 34 fields · synced Jun 1, 2026