A&E Medical / Wire Twister

FDA UDI

Class I (US FDA UDI)

by A & E Medical Corporation

Identity

Trade Name: A&E Medical / Wire Twister FDA UDI
Generic Name: Wire twister FDA UDI
Device Name: MYO/Lead, 1 per pouch FDA UDI
Model / Reference: 019-501 FDA UDI
Description: MYO/Lead, 1 per pouch FDA UDI

Identifiers

Primary DI / UDI-DI: 10841291105367 FDA UDI
FDA Product Code: HXS FDA UDI
GMDN Term: Wire twister FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

Category: Wire twister

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

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Also classified as Wire twister.

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NEW ORLEANS WIRE TWISTER — SONTEC INSTRUMENTS, INC. · Class I
MCGEE WIRE CLOSURE FORCEPS — SONTEC INSTRUMENTS, INC. · Class I
Life Instruments — Life Instrument Corporation · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: A & E Medical Corporation

Sources (1)

FDA UDI 84f614a5-da91-4ecb-8a9f-f3d30068da2c 33 fields · synced Jun 8, 2026