← Back to catalogue

Flexon

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Flexon FDA UDI
Generic Name
Transthoracic pacing lead FDA UDI
Device Name
Multifilament Temporary Cardiac Pacing Lead FDA UDI
Model / Reference
88862623-53 FDA UDI
Description
Multifilament Temporary Cardiac Pacing Lead FDA UDI

Identifiers

Primary DI / UDI-DI
10884521103801 FDA UDI
510(k) Number
K955722 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

Dimensions & Sizes

Size
Length — 24 Inch FDA UDI

Category: Transthoracic pacing lead

Flexon by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transthoracic pacing lead.

Cleared under the same submission

K955722 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI e1af1e29-bf0d-434c-8272-7a88ab36405c 37 fields · synced May 31, 2026