Coil Expander

Basic Information

• Brand Name: Coil Expander
• Primary DI: 00827002200050
• Version / Model: G20005
• Catalog Number: LR-CEX001
• Company Name: Cook Vandergrift Inc.
• Labeler DUNS: 056867526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: dc91895d-ec85-41d8-8a2d-3274d8b8128e

Device Description

Coil Expander

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47025	Pacing/defibrillation lead extraction expander	A device designed to dilate the end of a cut implantable pacemaker or implantable cardioverter-defibrillator (ICD) lead, of the coil type, typically to enable correction of any deformities to the lead, allowing for accurate lead sizing with a gauge in preparation for lead extraction. It is a sterile device typically designed with a plastic handle, and a pointed, conical, metal distal tip that is inserted into the lead. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002200050	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.