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Ethicon

FDA UDI

Class II (US FDA UDI)

by Ethicon Inc.

Identity

Trade Name
ETHICON FDA UDI
Generic Name
Transthoracic pacing lead FDA UDI
Device Name
Temporary Cardiac Pacing Wire FDA UDI
Model / Reference
TPW32 FDA UDI
Description
Temporary Cardiac Pacing Wire FDA UDI

Identifiers

Catalog Number
TPW32 FDA UDI
Primary DI / UDI-DI
10705031050891 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

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

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Transthoracic pacing lead

Ethicon by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transthoracic pacing lead.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Inc.

Sources (1)

  • FDA UDI f9062c56-adb6-4164-aebb-f8b0e9f8ebd3 35 fields · synced Jun 1, 2026