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Lld Ez™

FDA UDI

Class II (US FDA UDI)

by Spectranetics Corporation

Identity

Trade Name
LLD EZ™ FDA UDI
Generic Name
Pacing/defibrillation lead stylet, extraction FDA UDI
Device Name
Lead Locking Device (LLD™ EZ) FDA UDI
Model / Reference
518-067AA FDA UDI
Description
Lead Locking Device (LLD™ EZ) FDA UDI

Identifiers

Catalog Number
518-067 FDA UDI
Primary DI / UDI-DI
00813132020835 FDA UDI
510(k) Number
K142116 FDA UDI
FDA Product Code
DRB FDA UDI
GMDN Term
Pacing/defibrillation lead stylet, extraction FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1380 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
Sterilization Method
Ethylene Oxide FDA UDI

Category: Pacing/defibrillation lead stylet, extraction

Lld Ez™ by Spectranetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pacing/defibrillation lead stylet, extraction.

Cleared under the same submission

K142116 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectranetics Corporation

Sources (1)

  • FDA UDI 60d494bb-c6ae-45b0-8238-8f9735eeecd3 37 fields · synced May 30, 2026