Model: A
Catalog: LR-LED01
DI: 00884450376157
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8a4b12f8-7894-4331-84a0-822a1cc466d0
Distribution Status:
In Commercial Distribution
DUNS Number:
184763290
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10884450376154
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
36
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884450376157
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884450376157
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 47024
Name: Pacing/defibrillation lead extraction extender
Definition:
A device intended to be used during the release and removal of a cut implantable pacemaker or implantable cardioverter-defibrillator (ICD) lead, of the solid type (lumenless), from surrounding tissue during lead extraction. It is a sterile wire with a loop and self-locking mechanism (e.g., a bulldog clamp) at the distal end which is attached to the end of the lead. After it has been secured to the lead, the surgeon can pull on it and apply tension to the lead whilst a sheath or similar type tissue removal tool is advanced down the device and over the lead to free the lead from adherent tissue. This is a single-use device.
FDA Product Codes
DWS
INSTRUMENTS, SURGICAL, CARDIOVASCULAR